COCCIDIOIDES IMMUNODIFFUSION SYSTEM

Antigen, Cf And / Or Id, Coccidioides Immitis

AMERICAN SCIENTIFIC PRODUCTS

The following data is part of a premarket notification filed by American Scientific Products with the FDA for Coccidioides Immunodiffusion System.

Pre-market Notification Details

Device IDK812190
510k NumberK812190
Device Name:COCCIDIOIDES IMMUNODIFFUSION SYSTEM
ClassificationAntigen, Cf And / Or Id, Coccidioides Immitis
Applicant AMERICAN SCIENTIFIC PRODUCTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMI  
CFR Regulation Number866.3135 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1981-08-03
Decision Date1981-08-31

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