URIC ACID REAGENT

Acid, Uric, Uricase (colorimetric)

DERMA MEDIA LAB., INC.

The following data is part of a premarket notification filed by Derma Media Lab., Inc. with the FDA for Uric Acid Reagent.

Pre-market Notification Details

Device IDK970867
510k NumberK970867
Device Name:URIC ACID REAGENT
ClassificationAcid, Uric, Uricase (colorimetric)
Applicant DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs,  CA  90670
ContactCharles C Allain
CorrespondentCharles C Allain
DERMA MEDIA LAB., INC. 8531 WELLSFORD PL., SUITE E Santa Fe Springs,  CA  90670
Product CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-10
Decision Date1997-04-21

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