TOXOSTAT M TEST KIT

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

WHITTAKER BIOPRODUCTS, INC.

The following data is part of a premarket notification filed by Whittaker Bioproducts, Inc. with the FDA for Toxostat M Test Kit.

Pre-market Notification Details

Device IDK875113
510k NumberK875113
Device Name:TOXOSTAT M TEST KIT
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
ContactMarie P Reeves
CorrespondentMarie P Reeves
WHITTAKER BIOPRODUCTS, INC. 8830 BRIGG FORD RD. Walkersville,  MD  21793
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-15
Decision Date1988-04-12

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