VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM

Radioimmunoassay, Thyroid-stimulating Hormone

Ortho-Clinical Diagnostics, Inc.

The following data is part of a premarket notification filed by Ortho-clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostic Products Tsh Reagent Pack And Calibrators, Vitros 5600 Integrated System.

Pre-market Notification Details

Device IDK081543
510k NumberK081543
Device Name:VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 5600 INTEGRATED SYSTEM
ClassificationRadioimmunoassay, Thyroid-stimulating Hormone
Applicant Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester,  NY  14626 -5101
ContactLeah Van De Water
CorrespondentLeah Van De Water
Ortho-Clinical Diagnostics, Inc. 100 INDIGO CREEK DRIVE MC881 Rochester,  NY  14626 -5101
Product CodeJLW  
Subsequent Product CodeDIP
Subsequent Product CodeJIT
Subsequent Product CodeJJE
CFR Regulation Number862.1690 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-06-02
Decision Date2008-10-23
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10758750033515 K081543 000
10758750009862 K081543 000
10758750007110 K081543 000
10758750002740 K081543 000

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