The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Blood Group Substance A,b.
Device ID | K781896 |
510k Number | K781896 |
Device Name: | BLOOD GROUP SUBSTANCE A,B |
Classification | Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use |
Applicant | NORTH AMERICAN BIOLOGICALS, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | KSX |
CFR Regulation Number | 864.9160 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-11-06 |
Decision Date | 1978-12-20 |