The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for 'rapidtec' 5a Multiple Dip Test.
| Device ID | K021114 |
| 510k Number | K021114 |
| Device Name: | 'RAPIDTEC' 5A MULTIPLE DIP TEST |
| Classification | Enzyme Immunoassay, Amphetamine |
| Applicant | AMERICAN BIO MEDICA CORP. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Contact | Henry Wells |
| Correspondent | Henry Wells AMERICAN BIO MEDICA CORP. 9110 RED BRANCH RD. Columbia, MD 21045 |
| Product Code | DKZ |
| Subsequent Product Code | DIO |
| Subsequent Product Code | DJG |
| Subsequent Product Code | LCM |
| Subsequent Product Code | LDJ |
| CFR Regulation Number | 862.3100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-05 |
| Decision Date | 2002-07-23 |
| Summary: | summary |