Ammonia II

Enzymatic Method, Ammonia

Roche Diagnostics Operations (RDO)

The following data is part of a premarket notification filed by Roche Diagnostics Operations (rdo) with the FDA for Ammonia Ii.

Pre-market Notification Details

Device IDK183517
510k NumberK183517
Device Name:Ammonia II
ClassificationEnzymatic Method, Ammonia
Applicant Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis,  IN  46250
ContactNoel B. Mencias
CorrespondentNoel B. Mencias
Roche Diagnostics Operations (RDO) 9115 Hague Road Indianapolis,  IN  46250
Product CodeJIF  
CFR Regulation Number862.1065 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-12-18
Decision Date2019-02-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04015630936526 K183517 000
04015630936533 K183517 000
07613336121429 K183517 000

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