Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSH

Hexokinase, Glucose

Roche Diagnostics

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

Pre-market Notification Details

Device IDK220134
510k NumberK220134
Device Name:Cobas Pure Integrated Solutions, Glucose HK Gen.3, ISE Indirect Na For Gen.2, ONLINE DAT Methadone II, Elecsys TSH
ClassificationHexokinase, Glucose
Applicant Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
ContactNoel Mencias
CorrespondentNoel Mencias
Roche Diagnostics 9115 Hague Road Indianapolis,  IN  46250
Product CodeCFR  
Subsequent Product CodeDJR
Subsequent Product CodeJGS
Subsequent Product CodeJJE
Subsequent Product CodeJLW
CFR Regulation Number862.1345 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-01-18
Decision Date2022-09-16

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