The following data is part of a premarket notification filed by Micro Typing Systems Inc. with the FDA for Blood Bank Supplies.
Device ID | BK980016 |
510k Number | BK980016 |
Device Name: | Blood Bank Supplies |
Classification | Supplies, Blood-bank |
Applicant | Micro Typing Systems Inc. 1295 S.w. 29th Ave. Pompano Beach, FL 33069 |
Product Code | KSS |
CFR Regulation Number | 864.9050 [🔎] |
Decision | Substantially Equivalent (SE) |
Type | 510(k) Traditio |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-06-05 |
Decision Date | 1998-10-29 |