The following data is part of a premarket notification filed by Kent Laboratories, Inc. with the FDA for Antiserum, Human, Iga.
| Device ID | K790703 |
| 510k Number | K790703 |
| Device Name: | ANTISERUM, HUMAN, IGA |
| Classification | Iga, Antigen, Antiserum, Control |
| Applicant | KENT LABORATORIES, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CZP |
| CFR Regulation Number | 866.5510 [🔎] |
| Decision | Se - Postmarket Surveillance Required (SESP) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-04-12 |
| Decision Date | 1979-04-12 |