The following data is part of a premarket notification filed by Bionike Laboratories, Inc. with the FDA for Bionike Aq Phencyclidine (pcp) Test.
| Device ID | K993945 |
| 510k Number | K993945 |
| Device Name: | BIONIKE AQ PHENCYCLIDINE (PCP) TEST |
| Classification | Enzyme Immunoassay, Phencyclidine |
| Applicant | BIONIKE LABORATORIES, INC. 1420 LOS ANGELES AVE. SUITE 201 Simi Valley, CA 93065 |
| Contact | Cleve W Laird |
| Correspondent | James M Barquest CALIFORNIA DEPARTMENT OF HEALTH SERVICES P.O. BOX 942732 (MS-357) Sacramento, CA 94234 -7320 |
| Product Code | LCM |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 1999-11-19 |
| Decision Date | 1999-12-07 |
| Summary: | summary |