The following data is part of a premarket notification filed by Gamma Medical Products, Inc. with the FDA for Gmp Ciq Elisa Test Kit.
| Device ID | K833275 |
| 510k Number | K833275 |
| Device Name: | GMP CIQ ELISA TEST KIT |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | GAMMA MEDICAL PRODUCTS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-21 |
| Decision Date | 1984-06-22 |