CELL-DYN RAPID-LYSE AND HEMOGLOBLIN

Cyanomethemoglobin Reagent And Standard Solution

ABBOTT DIAGNOSTICS

The following data is part of a premarket notification filed by Abbott Diagnostics with the FDA for Cell-dyn Rapid-lyse And Hemogloblin.

Pre-market Notification Details

Device IDK881242
510k NumberK881242
Device Name:CELL-DYN RAPID-LYSE AND HEMOGLOBLIN
ClassificationCyanomethemoglobin Reagent And Standard Solution
Applicant ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View,  CA  94043
ContactRuth M Becker
CorrespondentRuth M Becker
ABBOTT DIAGNOSTICS 850 MAUDE AVE. Mountain View,  CA  94043
Product CodeGJZ  
CFR Regulation Number864.7500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-16
Decision Date1988-04-21

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