HEMAWIPE SYSTEM, THE CIVILIZED TEST

Reagent, Occult Blood

LABELTAPE MEDITECT, INC.

The following data is part of a premarket notification filed by Labeltape Meditect, Inc. with the FDA for Hemawipe System, The Civilized Test.

Pre-market Notification Details

Device IDK884206
510k NumberK884206
Device Name:HEMAWIPE SYSTEM, THE CIVILIZED TEST
ClassificationReagent, Occult Blood
Applicant LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
ContactLora Jones
CorrespondentLora Jones
LABELTAPE MEDITECT, INC. 4275 AIRWEST DR., S.E. P.O. BOX 8823 Grand Rapids,  MI  49508
Product CodeKHE  
CFR Regulation Number864.6550 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-06
Decision Date1989-04-18

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