ACCU-STAPH

Staphylococcus Aureus Somatic Antigens

CARR-SCARBOROUGH MICROBIOLOGICALS, INC.

The following data is part of a premarket notification filed by Carr-scarborough Microbiologicals, Inc. with the FDA for Accu-staph.

Pre-market Notification Details

Device IDK820347
510k NumberK820347
Device Name:ACCU-STAPH
ClassificationStaphylococcus Aureus Somatic Antigens
Applicant CARR-SCARBOROUGH MICROBIOLOGICALS, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeLHT  
CFR Regulation Number866.3700 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-02-08
Decision Date1982-03-04

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