HEMOCARD HEMOGLOBIN S

Test, Sickle Cell

ISOLAB, INC.

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

Pre-market Notification Details

Device IDK911981
510k NumberK911981
Device Name:HEMOCARD HEMOGLOBIN S
ClassificationTest, Sickle Cell
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactJanet D Perkins
CorrespondentJanet D Perkins
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeGHM  
CFR Regulation Number864.7825 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-05-03
Decision Date1991-10-09

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