The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Quality Control Kits For Blood Banking Reagents.
Device ID | BK150280 |
510k Number | BK150280 |
Device Name: | Quality Control Kits For Blood Banking Reagents |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach, FL 33069 |
Product Code | KSF |
CFR Regulation Number | 864.9650 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2015-06-16 |
Decision Date | 2015-08-14 |