The following data is part of a premarket notification filed by Bionike, Inc. with the FDA for Bionike Aq Barbiturate Test.
| Device ID | K990280 |
| 510k Number | K990280 |
| Device Name: | BIONIKE AQ BARBITURATE TEST |
| Classification | Enzyme Immunoassay, Barbiturate |
| Applicant | BIONIKE, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | Cleve W Laird BIONIKE, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Product Code | DIS |
| CFR Regulation Number | 862.3150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-28 |
| Decision Date | 1999-06-28 |
| Summary: | summary |