POLYCHACO INDIRECT HEMAGGLUTINATION

Antigens, Iha, Toxoplasma Gondii

PARASITIC DISEASE CONSULTANTS

The following data is part of a premarket notification filed by Parasitic Disease Consultants with the FDA for Polychaco Indirect Hemagglutination.

Pre-market Notification Details

Device IDK830870
510k NumberK830870
Device Name:POLYCHACO INDIRECT HEMAGGLUTINATION
ClassificationAntigens, Iha, Toxoplasma Gondii
Applicant PARASITIC DISEASE CONSULTANTS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeGMM  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-03-18
Decision Date1983-08-12

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