American Bio Medica Corp.: FDA filings under this applicant name
FDA lists 30 510(k) clearances under the applicant name “American Bio Medica Corp.” (first 1997, latest 2017), across 12 product codes in 1 review panel. Median 510(k) review time under this name: 114 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 | 1 | 202 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name American Bio Medica Corp. took a median 202 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 142 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DKZ | Enzyme Immunoassay, Amphetamine | 9 | 9 |
| DIO | Enzyme Immunoassay, Cocaine And Cocaine Metabolites | 4 | 4 |
| DJG | Enzyme Immunoassay, Opiates | 4 | 4 |
| LDJ | Enzyme Immunoassay, Cannabinoids | 3 | 3 |
| DIS | Enzyme Immunoassay, Barbiturate | 2 | 2 |
| DJR | Enzyme Immunoassay, Methadone | 2 | 2 |
| DJC | Thin Layer Chromatography, Methamphetamine | 1 | 1 |
| DOD | Gas Chromatography, Amphetamine | 1 | 1 |
| JXM | Enzyme Immunoassay, Benzodiazepine | 1 | 1 |
| JXN | Enzyme Immunoassay, Propoxyphene | 1 | 1 |
Plus 2 more product codes.
Review panels
- Clinical Toxicology (30)
Most recent American Bio Medica Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170222 | Rapid Tox Cup II | LAF | 2017-08-15 | 202 |
| K073078 | RAPID TOX CUP | LAG | 2008-05-30 | 212 |
| K060760 | RAPIDONE-BUPRENORPHINE TEST | DJG | 2006-08-07 | 139 |
| K053422 | RAPIDONE-COCAINE-150 TEST | DIO | 2006-06-15 | 189 |
| K053359 | RAPIDTOX | DKZ | 2006-05-25 | 174 |
| K041696 | RAPID READER | DKZ | 2005-07-12 | 385 |
| K041712 | 'RAPIDTEC 4' TEST | DIS | 2004-11-03 | 133 |
| K030835 | 'RAPID ONE' - PROPOXYPHENE TEST | JXN | 2003-05-22 | 66 |
| K023869 | 'RAPIDTEC'-5M-MULTIPLE DIP TEST | DJR | 2003-04-30 | 161 |
| K021114 | 'RAPIDTEC' 5A MULTIPLE DIP TEST | DKZ | 2002-07-23 | 109 |
20 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named American Bio Medica 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.
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 Bio Medica Corp.?
FDA lists 30 510(k) clearances under the applicant name “American Bio Medica Corp.” (first 1997, latest 2017), across 12 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 Bio Medica Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name American Bio Medica Corp. is 114 days.
Which FDA product codes appear under American Bio Medica Corp.?
The most frequent FDA product codes under this applicant name are DKZ (Enzyme Immunoassay, Amphetamine, 9); DIO (Enzyme Immunoassay, Cocaine And Cocaine Metabolites, 4); DJG (Enzyme Immunoassay, Opiates, 4).
Next steps
- See all 30 American Bio Medica Corp. clearances with predicates and recalls
- Run predicate analysis for product code DKZ, American Bio Medica 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, 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.