HEMOCARD CONTROL

Control, Hemoglobin, Abnormal

ISOLAB, INC.

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

Pre-market Notification Details

Device IDK910431
510k NumberK910431
Device Name:HEMOCARD CONTROL
ClassificationControl, Hemoglobin, Abnormal
Applicant ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
ContactJanet D Perkins
CorrespondentJanet D Perkins
ISOLAB, INC. DRAWER 4350 Akron,  OH  44321
Product CodeJCM  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-01
Decision Date1991-03-11

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.