The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
| Device ID | BK900021 |
| 510k Number | BK900021 |
| Device Name: | Quality Control Kits For Blood Banking Reagents |
| Classification | Kit, Quality Control For Blood Banking Reagents |
| Applicant | Gamma Biologicals, Inc. 3700 Mangum Road Houston, TX 77092 |
| Product Code | KSF |
| CFR Regulation Number | 864.9650 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-07 |
| Decision Date | 1990-10-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234001751 | BK900021 | 0 |
| 10888234001744 | BK900021 | 0 |