The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for 'rapid One' - Propoxyphene Test.
| Device ID | K030835 |
| 510k Number | K030835 |
| Device Name: | 'RAPID ONE' - PROPOXYPHENE TEST |
| Classification | Enzyme Immunoassay, Propoxyphene |
| 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 | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-17 |
| Decision Date | 2003-05-22 |
| Summary: | summary |