GLYC-AFFIN(TM)-GA

Assay, Glycosylated Hemoglobin

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Glyc-affin(tm)-ga.

Pre-market Notification Details

Device IDK905513
510k NumberK905513
Device Name:GLYC-AFFIN(TM)-GA
ClassificationAssay, Glycosylated Hemoglobin
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactLoren F Hazelwood
CorrespondentLoren F Hazelwood
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeLCP  
CFR Regulation Number864.7470 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-12-10
Decision Date1991-01-15

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