The following data is part of a premarket notification filed by American Bio Medica Corp. with the FDA for Rapidone- Barbiturate Test.
| Device ID | K992451 |
| 510k Number | K992451 |
| Device Name: | RAPIDONE- BARBITURATE TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| 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 | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-22 |
| Decision Date | 2000-04-03 |
| Summary: | summary |