The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for 'rapid Drug Screen' 8 Panel-low Volume.
| Device ID | K981705 |
| 510k Number | K981705 |
| Device Name: | 'RAPID DRUG SCREEN' 8 PANEL-LOW VOLUME |
| Classification | Enzyme Immunoassay, Amphetamine |
| 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 | DKZ |
| Subsequent Product Code | DDG |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DIS |
| Subsequent Product Code | JXM |
| Subsequent Product Code | LCL |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-14 |
| Decision Date | 1998-08-27 |