The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for In Vitro Phenobarbital Ria Test.
| Device ID | K772111 |
| 510k Number | K772111 |
| Device Name: | IN VITRO PHENOBARBITAL RIA TEST |
| Classification | Radioimmunoassay, Phenobarbital |
| Applicant | CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DKP |
| CFR Regulation Number | 862.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-07 |
| Decision Date | 1977-11-28 |