The following data is part of a premarket notification filed by Gamma Medical Products, Inc. with the FDA for Gamma Clq.
| Device ID | K823009 |
| 510k Number | K823009 |
| Device Name: | GAMMA CLQ |
| Classification | Complement C1q, Antigen, Antiserum, Control |
| Applicant | GAMMA MEDICAL PRODUCTS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DAK |
| CFR Regulation Number | 866.5240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-10-12 |
| Decision Date | 1982-11-05 |