ANTI-HISTOPLASMA SERUM #CF10026X

Antiserum, Positive Control, Histoplasma Capsulatum

IMMUNO-MYCOLOGICS, INC.

The following data is part of a premarket notification filed by Immuno-mycologics, Inc. with the FDA for Anti-histoplasma Serum #cf10026x.

Pre-market Notification Details

Device IDK791392
510k NumberK791392
Device Name:ANTI-HISTOPLASMA SERUM #CF10026X
ClassificationAntiserum, Positive Control, Histoplasma Capsulatum
Applicant IMMUNO-MYCOLOGICS, INC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMK  
CFR Regulation Number866.3320 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1979-07-11
Decision Date1979-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816387020384 K791392 000

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