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 |