CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION

Antisera, Latex Agglutination, Cryptococcus Neoformans

IMMUNO-MYCOLOGICS, INC.

The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Cryptococcal Antigen Latex Agglutination.

Pre-market Notification Details

Device IDK791382
510k NumberK791382
Device Name:CRYPTOCOCCAL ANTIGEN LATEX AGGLUTINATION
ClassificationAntisera, Latex Agglutination, Cryptococcus Neoformans
Applicant IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMD  
CFR Regulation Number866.3165 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-11
Decision Date1979-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816387020834 K791382 000
00816387020827 K791382 000

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