The following data is part of a premarket notification filed by Immunalysis Corporation with the FDA for Phencyclidine Direct Blood Ria Kit.
| Device ID | K800514 |
| 510k Number | K800514 |
| Device Name: | PHENCYCLIDINE DIRECT BLOOD RIA KIT |
| Classification | Radioimmunoassay, Phencyclidine |
| Applicant | Immunalysis Corporation 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | LCL |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-05 |
| Decision Date | 1980-03-19 |