DCA 2000 + MICROALBUMIN/CREATININE ASSAY

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

BAYER CORP.

The following data is part of a premarket notification filed by Bayer Corp. with the FDA for Dca 2000 + Microalbumin/creatinine Assay.

Pre-market Notification Details

Device IDK963142
510k NumberK963142
Device Name:DCA 2000 + MICROALBUMIN/CREATININE ASSAY
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
Applicant BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart,  IN  46514 -0070
ContactRosanne M Savol, R.a.c.
CorrespondentRosanne M Savol, R.a.c.
BAYER CORP. 1884 MILES AVE. P.O. BOX 70 Elkhart,  IN  46514 -0070
Product CodeJIR  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-08-13
Decision Date1996-09-27
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414535722 K963142 000
00630414532790 K963142 000
00630414027364 K963142 000

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