The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapid Drug Screen 5-panel Drug Screening Test For Cocaine, Marijuana, Opiates, Amphetamine And Methamphetamine.
| Device ID | K993796 |
| 510k Number | K993796 |
| Device Name: | RAPID DRUG SCREEN 5-PANEL DRUG SCREENING TEST FOR COCAINE, MARIJUANA, OPIATES, AMPHETAMINE AND METHAMPHETAMINE |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | AMERICAN BIO MEDICA CORP. 300 FAIRVIEW AVE. Hudson, NY 12534 |
| Contact | Henry Wells |
| Correspondent | Henry Wells AMERICAN BIO MEDICA CORP. 300 FAIRVIEW AVE. Hudson, NY 12534 |
| Product Code | LDJ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | DKZ |
| Subsequent Product Code | LAF |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-11-09 |
| Decision Date | 1999-12-21 |
| Summary: | summary |