RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)

Enzymatic Method, Creatinine

REAGENTS APPLICATIONS, INC.

The following data is part of a premarket notification filed by Reagents Applications, Inc. with the FDA for Raichem(tm) Creatinine Reagent (enzymatic).

Pre-market Notification Details

Device IDK864992
510k NumberK864992
Device Name:RAICHEM(TM) CREATININE REAGENT (ENZYMATIC)
ClassificationEnzymatic Method, Creatinine
Applicant REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
ContactAlfred E Peacock,jr
CorrespondentAlfred E Peacock,jr
REAGENTS APPLICATIONS, INC. 8225 MERCURY CT. San Diego,  CA  92111 -1203
Product CodeJFY  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-22
Decision Date1987-02-12

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