The following data is part of a premarket notification filed by Clinical Assays, Inc. with the FDA for Gamma Coat(125 I) Rubella Antibody.
| Device ID | K801667 |
| 510k Number | K801667 |
| Device Name: | GAMMA COAT(125 I) RUBELLA ANTIBODY |
| Classification | Antigen, Ha (including Ha Control), Rubella |
| Applicant | CLINICAL ASSAYS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GOL |
| CFR Regulation Number | 866.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-07-21 |
| Decision Date | 1980-10-23 |