The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapidone - Opiates Test.
| Device ID | K990820 |
| 510k Number | K990820 |
| Device Name: | RAPIDONE - OPIATES TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | AMERICAN BIO MEDICA CORP. 1001 G STREET, NW SUITE 500W Washington, DC 20001 |
| Contact | John B Dubeck |
| Correspondent | John B Dubeck AMERICAN BIO MEDICA CORP. 1001 G STREET, NW SUITE 500W Washington, DC 20001 |
| Product Code | DJG |
| Subsequent Product Code | DJF |
| Subsequent Product Code | DMY |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-11 |
| Decision Date | 1999-07-15 |
| Summary: | summary |