The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Blood Bank Centrifuges For In Vitro Diagnostic Use.
| Device ID | BK960077 |
| 510k Number | BK960077 |
| Device Name: | Blood Bank Centrifuges For In Vitro Diagnostic Use |
| Classification | Centrifuge, Blood-bank For In Vitro Diagnostic Use |
| Applicant | Gamma Biologicals, Inc. 3700 Mangum Road Houston, TX 77092 |
| Product Code | KSO |
| CFR Regulation Number | 864.9275 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-15 |
| Decision Date | 1997-09-18 |