The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for 'rapidtec 4' Test.
| Device ID | K041712 |
| 510k Number | K041712 |
| Device Name: | 'RAPIDTEC 4' TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DJR |
| Subsequent Product Code | JXM |
| Subsequent Product Code | JXN |
| Subsequent Product Code | LFG |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-23 |
| Decision Date | 2004-11-03 |