The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Stabilized Enzyme Solutions.
| Device ID | BK920030 |
| 510k Number | BK920030 |
| Device Name: | Stabilized Enzyme Solutions |
| Classification | Solution, Stabilized Enzyme |
| Applicant | Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach, FL 33069 |
| 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 | 1992-10-19 |
| Decision Date | 1993-09-29 |