Microscan Div. Baxter Healthcare Corp.: FDA filings under this applicant name
FDA lists 11 510(k) clearances under the applicant name “Microscan Div. Baxter Healthcare Corp.” (first 1987, latest 1987), across 8 product codes in 2 review panels. Median 510(k) review time under this name: 91 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 Danaher (Beckman Coulter, Leica Biosystems, Radiometer, Cepheid), 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 |
|---|---|---|---|
| GQS | Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4 | 3 | 3 |
| GNX | Antigens, Cf (Including Cf Control), Influenza Virus A, B, C | 2 | 2 |
| GOD | Antigens, Cf (Including Cf Control), Adenovirus 1-33 | 1 | 1 |
| GQL | Antisera, Fluorescent, Herpesvirus Hominis 1,2 | 1 | 1 |
| GTJ | Antisera, All Groups, N. Meningitidis | 1 | 1 |
| JWY | Manual Antimicrobial Susceptibility Test Systems | 1 | 1 |
| KIR | Cells, Animal And Human, Cultured | 1 | 1 |
| LKT | Respiratory Syncytial Virus, Antigen, Antibody, Ifa | 1 | 1 |
Review panels
- Microbiology (10)
- Pathology (1)
Most recent Microscan Div. Baxter Healthcare Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K871234 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 1 | GQS | 1987-06-26 | 91 |
| K871233 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA A | GNX | 1987-06-26 | 91 |
| K871232 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 3 | GQS | 1987-06-26 | 91 |
| K871231 | ANTIBODY ASSAY FOR DETECTION OF INFLUENZA B | GNX | 1987-06-26 | 91 |
| K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS | LKT | 1987-06-26 | 91 |
| K871229 | ANTIBODY ASSAY FOR DETECTION OF ADENOVIRUS IN CELL | GOD | 1987-06-26 | 91 |
| K871228 | ANTIBODY ASSAY FOR DETECT. OF PARAINFLUENZA TYPE 2 | GQS | 1987-06-26 | 91 |
| K870814 | HERPES SIMPLEX ANTIBODY TEST FOR DECT. OF HSV 1&2 | GQL | 1987-06-04 | 93 |
| K870074 | GRAM NEGATIVE AND GRAM POSITIVE MIC/COMBO PANELS | JWY | 1987-04-14 | 96 |
| K871033 | RABBIT KIDNEY CULTURE CELLS (FIRST PASS) | KIR | 1987-03-31 | 15 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Microscan Div. Baxter Healthcare Corp..
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 Microscan Div. Baxter Healthcare Corp. (a text match, not an official crosswalk):
Frequently asked questions
How many FDA 510(k) clearances are listed under Microscan Div. Baxter Healthcare Corp.?
FDA lists 11 510(k) clearances under the applicant name “Microscan Div. Baxter Healthcare Corp.” (first 1987, latest 1987), across 8 product codes in 2 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 Microscan Div. Baxter Healthcare Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Microscan Div. Baxter Healthcare Corp. is 91 days.
Which FDA product codes appear under Microscan Div. Baxter Healthcare Corp.?
The most frequent FDA product codes under this applicant name are GQS (Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4, 3); GNX (Antigens, Cf (Including Cf Control), Influenza Virus A, B, C, 2); GOD (Antigens, Cf (Including Cf Control), Adenovirus 1-33, 1).
Next steps
- See all 11 Microscan Div. Baxter Healthcare Corp. clearances with predicates and recalls
- Run predicate analysis for product code GQS, Microscan Div. Baxter Healthcare Corp.'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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.