Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions

Hexokinase, Glucose

Roche Diagnostics

The following data is part of a premarket notification filed by Roche Diagnostics with the FDA for Glucose Hk Gen.3, Ise Indirect Na For Gen.2, Elecsys Tsh, Cobas Pro Integrated Solutions.

Pre-market Notification Details

Device IDK191899
510k NumberK191899
Device Name:Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions
ClassificationHexokinase, Glucose
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactKhoa Tran
CorrespondentKhoa Tran
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeCFR  
Subsequent Product CodeJGS
Subsequent Product CodeJJE
Subsequent Product CodeJLW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-07-16
Decision Date2019-08-16

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613336121283 K191899 000

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