URINE CALIBRATOR

Calibrators, Drug Mixture

DIAGNOSTIC REAGENTS, INC.

The following data is part of a premarket notification filed by Diagnostic Reagents, Inc. with the FDA for Urine Calibrator.

Pre-market Notification Details

Device IDK940935
510k NumberK940935
Device Name:URINE CALIBRATOR
ClassificationCalibrators, Drug Mixture
Applicant DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
ContactYuh-geng Tsay, Ph.d
CorrespondentYuh-geng Tsay, Ph.d
DIAGNOSTIC REAGENTS, INC. 110 PIONEER WAY Mountain View,  CA  94041
Product CodeDKB  
CFR Regulation Number862.3200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-02-25
Decision Date1994-07-06

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00380740005474 K940935 000
00380740005467 K940935 000
00380740005450 K940935 000
00380740005443 K940935 000
00884883005044 K940935 000

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