CREATININE 340 (ENZYMATIC)

Alkaline Picrate, Colorimetry, Creatinine

SCLAVO, INC.

The following data is part of a premarket notification filed by Sclavo, Inc. with the FDA for Creatinine 340 (enzymatic).

Pre-market Notification Details

Device IDK895847
510k NumberK895847
Device Name:CREATININE 340 (ENZYMATIC)
ClassificationAlkaline Picrate, Colorimetry, Creatinine
Applicant SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
ContactKing, Ph.d.
CorrespondentKing, Ph.d.
SCLAVO, INC. 5 MANSARD COURT Wayne,  NJ  07470
Product CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-10-03
Decision Date1989-10-30

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