The following data is part of a premarket notification filed by Bionike Laboratories, Inc. with the FDA for Aq Opiates (morphine) Test.
| Device ID | K971361 |
| 510k Number | K971361 |
| Device Name: | AQ OPIATES (MORPHINE) TEST |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
| Contact | Janis Freestone |
| Correspondent | Janis Freestone BIONIKE LABORATORIES, INC. 1015 GRANDVIEW DR. South San Francisco, CA 94080 -4910 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-11 |
| Decision Date | 1997-06-06 |