ANTI-HISTOPLASMA CONTROL SERUM (YEAST)

Antiserum, Positive Control, Histoplasma Capsulatum

I M, INC.

The following data is part of a premarket notification filed by I M, Inc. with the FDA for Anti-histoplasma Control Serum (yeast).

Pre-market Notification Details

Device IDK760832
510k NumberK760832
Device Name:ANTI-HISTOPLASMA CONTROL SERUM (YEAST)
ClassificationAntiserum, Positive Control, Histoplasma Capsulatum
Applicant I M, 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 Received1976-10-13
Decision Date1976-11-01

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