The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapidone-cocaine-150 Test.
| Device ID | K053422 |
| 510k Number | K053422 |
| Device Name: | RAPIDONE-COCAINE-150 TEST |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| Applicant | AMERICAN BIO MEDICA CORP. 9110 RED BRANCH ROAD SUITE B Columbia, MD 21045 |
| Contact | Henry Wells |
| Correspondent | Henry Wells AMERICAN BIO MEDICA CORP. 9110 RED BRANCH ROAD SUITE B Columbia, MD 21045 |
| Product Code | DIO |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-08 |
| Decision Date | 2006-06-15 |
| Summary: | summary |