The following data is part of a premarket notification filed by Gamma Biologicals, Inc. with the FDA for Stabilized Enzyme Solutions.
| Device ID | BK880016 |
| 510k Number | BK880016 |
| Device Name: | Stabilized Enzyme Solutions |
| Classification | Solution, Stabilized Enzyme |
| Applicant | Gamma Biologicals, Inc. 3700 Mangum Road Houston, TX 77092 |
| Product Code | KSK |
| CFR Regulation Number | 864.9400 [🔎] |
| Decision | Substantially Equivalent (SE) |
| Type | 510(k) Traditio |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-06-15 |
| Decision Date | 1988-08-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888234000716 | BK880016 | 0 |
| 10888234000709 | BK880016 | 0 |