The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapid Drug Screen' 8 Panel.
| Device ID | K980872 |
| 510k Number | K980872 |
| Device Name: | RAPID DRUG SCREEN' 8 PANEL |
| Classification | Enzyme Immunoassay, Cocaine And Cocaine Metabolites |
| 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 | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LAF |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-06 |
| Decision Date | 1998-03-20 |