General Biometrics, Inc.: FDA filings under this applicant name
FDA lists 23 510(k) clearances under the applicant name “General Biometrics, Inc.” (first 1989, latest 1992), across 11 product codes in 2 review panels. Median 510(k) review time under this name: 46 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| LSR | Reagent, Borrelia Serological Reagent | 4 | 4 |
| LFX | Enzyme Linked Immunoabsorbent Assay, Rubella | 3 | 3 |
| LLL | Extractable Antinuclear Antibody, Antigen And Control | 3 | 3 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 2 | 2 |
| LJM | Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls | 2 | 2 |
| LKO | Anti-Rnp Antibody, Antigen And Control | 2 | 2 |
| LKP | Anti-Sm Antibody, Antigen And Control | 2 | 2 |
| MID | System, Test, Anticardiolipin Immunological | 2 | 2 |
| DHC | System, Test, Systemic Lupus Erythematosus | 1 | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 | 1 |
Plus 1 more product codes.
Review panels
- Immunology (15)
- Microbiology (8)
Most recent General Biometrics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K924843 | IMMUNODOT(R) ENA/DNA AUTOIMMUNITY SCREENING PANEL | LLL | 1992-12-01 | 64 |
| K920401 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGM) TEST | MID | 1992-08-20 | 204 |
| K920400 | IMMUNOWELL CARDIOLIPIN ANTIBODY (IGG) TEST | MID | 1992-08-20 | 204 |
| K911627 | IMMUNODOT BORRELIA (LYME) TEST | LSR | 1992-04-08 | 363 |
| K911599 | IMMUNOWELL LYME (P39 RECOMBINANT) TEST | LSR | 1991-12-30 | 265 |
| K911590 | IMMUNOWELL BORRELIA (LYME)TEST | LSR | 1991-12-20 | 255 |
| K914801 | IMMUNOWELL DSDNA ANTIBODY TEST | DHC | 1991-12-09 | 46 |
| K911851 | IMMUNOWELL SM ANTIBODY TEST | LKP | 1991-05-07 | 11 |
| K911850 | IMMUNWELL SJOGREN`S SYNDROME B (LA) ANTIBODY TEST | LKO | 1991-05-07 | 11 |
| K911849 | IMMUNOWELL SJOGRENS SYNDROME A (RO)ANTIBODY TEST | LKO | 1991-05-07 | 11 |
13 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named General Biometrics, 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.
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.
- General Electric Co. (254 510(k)s)
- General Diagnostics (39 510(k)s)
- General Electric Medical Systems Information Techn (33 510(k)s)
- General Medical Co. (15 510(k)s)
- General Surgical Innovations (14 510(k)s)
- General X-Ray, Inc. (14 510(k)s)
- General Devices (13 510(k)s)
- General Physiotherapy, Inc. (9 510(k)s)
- General Medical Merate S.P.A (7 510(k)s)
- General Theraphysical, Inc. (7 510(k)s)
- General Atomics (6 510(k)s)
- General Electric Medical Systems (6 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under General Biometrics, Inc.?
FDA lists 23 510(k) clearances under the applicant name “General Biometrics, Inc.” (first 1989, latest 1992), across 11 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 General Biometrics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name General Biometrics, Inc. is 46 days.
Which FDA product codes appear under General Biometrics, Inc.?
The most frequent FDA product codes under this applicant name are LSR (Reagent, Borrelia Serological Reagent, 4); LFX (Enzyme Linked Immunoabsorbent Assay, Rubella, 3); LLL (Extractable Antinuclear Antibody, Antigen And Control, 3).
Next steps
- See all 23 General Biometrics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code LSR, General Biometrics, 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.