IRISPEC URINE CHEMISTRY CONTROL PART A AND B

Urinalysis Controls (assayed And Unassayed)

INTERNATIONAL REMOTE IMAGING SYSTEMS

The following data is part of a premarket notification filed by International Remote Imaging Systems with the FDA for Irispec Urine Chemistry Control Part A And B.

Pre-market Notification Details

Device IDK945913
510k NumberK945913
Device Name:IRISPEC URINE CHEMISTRY CONTROL PART A AND B
ClassificationUrinalysis Controls (assayed And Unassayed)
Applicant INTERNATIONAL REMOTE IMAGING SYSTEMS 9825 DE SOTO AVE. Chartsworth,  CA  91311
ContactSanford Widran
CorrespondentSanford Widran
INTERNATIONAL REMOTE IMAGING SYSTEMS 9825 DE SOTO AVE. Chartsworth,  CA  91311
Product CodeJJW  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1994-12-02
Decision Date1995-04-05

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