The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for In Vitro Gammacoat B-hcg Radio. Test.
| Device ID | K823313 |
| 510k Number | K823313 |
| Device Name: | IN VITRO GAMMACOAT B-HCG RADIO. TEST |
| Classification | Visual, Pregnancy Hcg, Prescription Use |
| Applicant | CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JHI |
| CFR Regulation Number | 862.1155 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-11-05 |
| Decision Date | 1982-12-22 |