HEMOCARD, HEMOGLOBIN C ASSAY

Hemoglobin C (abnormal Hemoglobin Variant)

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemocard, Hemoglobin C Assay.

Pre-market Notification Details

Device IDK923153
510k NumberK923153
Device Name:HEMOCARD, HEMOGLOBIN C ASSAY
ClassificationHemoglobin C (abnormal Hemoglobin Variant)
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactJanet D Perkins
CorrespondentJanet D Perkins
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeMLL  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-06-29
Decision Date1994-01-27

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