The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapidone-buprenorphine Test.
| Device ID | K060760 |
| 510k Number | K060760 |
| Device Name: | RAPIDONE-BUPRENORPHINE TEST |
| Classification | Enzyme Immunoassay, Opiates |
| 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 | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-08-07 |
| Summary: | summary |