INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)

Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii

INCSTAR CORP.

The following data is part of a premarket notification filed by Incstar Corp. with the FDA for Incstar Toxoplasma Igg Fast Elisa Assay (cat.#7560).

Pre-market Notification Details

Device IDK963297
510k NumberK963297
Device Name:INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560)
ClassificationEnzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Applicant INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
ContactMary Frick
CorrespondentMary Frick
INCSTAR CORP. 1990 INDUSTRIAL BLVD. P.O. BOX 285 Stillwater,  MN  55082
Product CodeLGD  
CFR Regulation Number866.3780 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-21
Decision Date1996-12-16
Summary:summary

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