Baxter Diagnostics, Inc.: FDA filings under this applicant name
FDA lists 72 510(k) clearances under the applicant name “Baxter Diagnostics, Inc.” (first 1988, latest 1995), across 44 product codes in 5 review panels. Median 510(k) review time under this name: 112 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Siemens Healthineers, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JWY | Manual Antimicrobial Susceptibility Test Systems | 12 | 12 |
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 5 | 5 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 4 | 4 |
| LTT | Panels, Test, Susceptibility, Antimicrobial | 3 | 3 |
| DDR | Myoglobin, Antigen, Antiserum, Control | 2 | 2 |
| GJS | Test, Time, Prothrombin | 2 | 2 |
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 2 | 2 |
| JLS | Radioimmunoassay, Progesterone | 2 | 2 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 2 | 2 |
| LGD | Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii | 2 | 2 |
Plus 34 more product codes.
Review panels
- Microbiology (39)
- Clinical Chemistry (17)
- Hematology (9)
- Clinical Toxicology (5)
- Immunology (2)
Most recent Baxter Diagnostics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934458 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | JWY | 1995-07-18 | 673 |
| K950817 | DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI | JWY | 1995-04-25 | 62 |
| K935704 | DRIED GRAM-NEGATIVE MIC//COMBO PANELS | LTT | 1995-04-14 | 500 |
| K950570 | STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY | JLS | 1995-04-11 | 67 |
| K945235 | DRIED GRAM-POSITIVE MIC/COMBO PANELS | LTT | 1995-03-07 | 131 |
| K941030 | DRIED GRAM-NEGATIVE CEFPODOXIME | LTT | 1995-02-16 | 349 |
| K940917 | LORACARBEF GRAM-NAGATIVE PANELS | JWY | 1995-02-08 | 348 |
| K941459 | GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX | JWY | 1995-02-03 | 316 |
| K941317 | DRIED GRAM NEGATIVE/CEFMETAZOLE | JWY | 1995-01-31 | 319 |
| K942267 | DRIED GRAM-POSITIVE MIC/COMBO PANELS/CEFMETAZOLE | JWY | 1995-01-09 | 244 |
62 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Baxter Diagnostics, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Baxter Diagnostics, Inc. (a text match, not an official crosswalk):
- J7197 — Antithrombin iii (human), per i.u. (via JBQ)
- G0008 — Administration of influenza virus vaccine (via GNX)
- J7213 — Injection, coagulation factor ix (recombinant), ixinity, 1 i.u. (via GJT)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Baxter Healthcare Corp (568 510(k)s)
- Baxter Edwards (11 510(k)s)
- Baxter Bentley Laboratories, Inc. (3 510(k)s)
- Baxter Healthcare Corportation (3 510(k)s)
- Baxter Healthcare Corporation - Renal Division (2 510(k)s)
- Baxter Corp. (1 510(k)s)
- Baxter Centre For Medical Research (1 510(k)s)
- Baxter Healthcare Corp., Bioscience (1 510(k)s)
- Baxter Healthcare Corp/ Excel Medical (1 510(k)s)
- Baxter Healthcare Corproration (1 510(k)s)
- Baxter Interwoven Offsite (1 510(k)s)
- Baxter Bio Science (0 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Baxter Diagnostics, Inc.?
FDA lists 72 510(k) clearances under the applicant name “Baxter Diagnostics, Inc.” (first 1988, latest 1995), across 44 product codes in 5 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Baxter Diagnostics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Baxter Diagnostics, Inc. is 112 days.
Which FDA product codes appear under Baxter Diagnostics, Inc.?
The most frequent FDA product codes under this applicant name are JWY (Manual Antimicrobial Susceptibility Test Systems, 12); JJY (Multi-Analyte Controls, All Kinds (Assayed), 5); LGC (Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific, 4).
Next steps
- See all 72 Baxter Diagnostics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JWY, Baxter Diagnostics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.