SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS

Diazo Colorimetry, Bilirubin

ARKRAY, INC.

The following data is part of a premarket notification filed by Arkray, Inc. with the FDA for Spotchem Ii Total Bilirubin, Total Protein And Albumin Tests.

Pre-market Notification Details

Device IDK051432
510k NumberK051432
Device Name:SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS
ClassificationDiazo Colorimetry, Bilirubin
Applicant ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor,  NY  10567
ContactHelen Landicho
CorrespondentHelen Landicho
ARKRAY, INC. 510 FURNACE DOCK RD. Cortlandt Manor,  NY  10567
Product CodeCIG  
Subsequent Product CodeCEK
Subsequent Product CodeCIX
CFR Regulation Number862.1110 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-06-01
Decision Date2005-06-17
Summary:summary

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