The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Blood Storage Refrigerators And Freezers.
Device ID | BK920004 |
510k Number | BK920004 |
Device Name: | Blood Storage Refrigerators And Freezers |
Classification | Refrigerator, Freezer, Blood Storage |
Applicant | Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach, FL 33069 |
Product Code | KSE |
CFR Regulation Number | 864.9700 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-01-21 |
Decision Date | 1992-03-12 |