BLOOD GROUP SUBSTANCE A

Substance, Blood Grouping Of Non-human Origin For In Vitro Diagnostic Use

NORTH AMERICAN BIOLOGICALS, INC.

The following data is part of a premarket notification filed by North American Biologicals, Inc. with the FDA for Blood Group Substance A.

Pre-market Notification Details

Device IDK781862
510k NumberK781862
Device Name:BLOOD GROUP SUBSTANCE A
ClassificationSubstance, 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 CodeKSX  
CFR Regulation Number864.9160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1978-11-06
Decision Date1978-12-20

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.