American Diagnostica, Inc.: FDA filings under this applicant name
FDA lists 10 510(k) clearances under the applicant name “American Diagnostica, Inc.” (first 1994, latest 2008), across 6 product codes in 1 review panel. Median 510(k) review time under this name: 158 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 |
|---|---|---|---|
| GGP | Test, Qualitative And Quantitative Factor Deficiency | 4 | 4 |
| KFF | Assay, Heparin | 2 | 2 |
| DAP | Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control | 1 | 1 |
| GIR | Reagent, Russel Viper Venom | 1 | 1 |
| GIZ | Plasma, Control, Normal | 1 | 1 |
| GJS | Test, Time, Prothrombin | 1 | 1 |
Review panels
- Hematology (10)
Most recent American Diagnostica, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K080069 | DIMERTEST | DAP | 2008-02-13 | 34 |
| K063323 | SPECTROLYSE PAI-1, MODEL 101201 | GGP | 2007-08-15 | 285 |
| K052124 | ACTICLOT, MODEL 824 | GJS | 2005-10-17 | 73 |
| K013637 | ACTICHROME HEPARIN (ANTI-FIIA) | KFF | 2002-04-16 | 162 |
| K013492 | IMUBIND TPA ELISA, MODEL 860 | GGP | 2002-03-13 | 142 |
| K013318 | ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 | KFF | 2002-03-08 | 154 |
| K013168 | IMUBIND PLASMA PAI-1 ELISA,MODEL 822 | GGP | 2002-03-07 | 167 |
| K012386 | ACTICLOT PROTEIN S, MODEL 843L | GGP | 2001-09-14 | 49 |
| K940490 | DV TEST AND DVV CONFIRM | GIR | 1995-04-05 | 426 |
| K935254 | DVVTEST AND DVVCONFIRM LUPUS ANTICOAGULANT NORMAL AND ABNORMAL CONTROL PLASMA | GIZ | 1994-09-19 | 322 |
Recalls
2 product recalls in 2 recall events; 0 initiated in the last five years. Most recent: 2010-03-05.
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.
- American Dade (149 510(k)s)
- American Edwards Laboratories (89 510(k)s)
- American Medical Systems, Inc. (82 510(k)s)
- American Bioproducts Co. (79 510(k)s)
- American Monitor Corp. (73 510(k)s)
- American Pharmaseal Div. Ahsc (64 510(k)s)
- American Bentley (59 510(k)s)
- American Hospital Supply Corp. (56 510(k)s)
- American Research Products Co. (56 510(k)s)
- American Orthodontics (46 510(k)s)
- American Diagnostic Corp. (39 510(k)s)
- American Laboratory Supply, Inc. (36 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under American Diagnostica, Inc.?
FDA lists 10 510(k) clearances under the applicant name “American Diagnostica, Inc.” (first 1994, latest 2008), across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by American Diagnostica, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Diagnostica, Inc. is 158 days.
Which FDA product codes appear under American Diagnostica, Inc.?
The most frequent FDA product codes under this applicant name are GGP (Test, Qualitative And Quantitative Factor Deficiency, 4); KFF (Assay, Heparin, 2); DAP (Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control, 1).
Next steps
- See all 10 American Diagnostica, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GGP, American Diagnostica, 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.