The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Kit, Quality Control For Blood Banking Reagents.
Device ID | BK900023 |
510k Number | BK900023 |
Device Name: | Kit, Quality Control For Blood Banking Reagents |
Classification | Kit, Quality Control For Blood Banking Reagents |
Applicant | North American Biologicals, Inc. 16500 N.w. 15th Avenue Miami, FL 33169 |
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 | 1991-07-29 |
Decision Date | 1991-11-13 |