HEMOCARD CONTROL HB-AA, AE, FAA, FAE

Control, Hemoglobin, Abnormal

ISOLAB, INC.

The following data is part of a premarket notification filed by Isolab, Inc. with the FDA for Hemocard Control Hb-aa, Ae, Faa, Fae.

Pre-market Notification Details

Device IDK931234
510k NumberK931234
Device Name:HEMOCARD CONTROL HB-AA, AE, FAA, FAE
ClassificationControl, Hemoglobin, Abnormal
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactJanet Perkins
CorrespondentJanet Perkins
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeJCM  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-03-10
Decision Date1993-05-11

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