The following data is part of a premarket notification filed by American Red Cross Blood Services with the FDA for Stabilized Enzyme Solutions.
| Device ID | BK880021 |
| 510k Number | BK880021 |
| Device Name: | Stabilized Enzyme Solutions |
| Classification | Solution, Stabilized Enzyme |
| Applicant | American Red Cross Blood Services 15601 Crabbs Branch Way Rockville, MD 20855 |
| 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 | 1988-07-25 |
| Decision Date | 1988-12-21 |