The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Rst-series Control.
| Device ID | K800658 |
| 510k Number | K800658 |
| Device Name: | RST-SERIES CONTROL |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | GAMMA BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-03-26 |
| Decision Date | 1980-04-16 |