The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Gamma Chloroquine Diphosphate Solution.
| Device ID | K813342 |
| 510k Number | K813342 |
| Device Name: | GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION |
| Classification | Solution, Stabilized Enzyme |
| Applicant | GAMMA BIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-11-25 |
| Decision Date | 1982-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000891 | K813342 | 000 |