ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK

System, Test, Osteocalcin

ROCHE DIAGNOSTICS CORP.

The following data is part of a premarket notification filed by Roche Diagnostics Corp. with the FDA for Elecsys N-mid Osteocalcin, Elecsys Osteocalcin Calset, Elecsys Osteocalcin Calcheck.

Pre-market Notification Details

Device IDK051297
510k NumberK051297
Device Name:ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK
ClassificationSystem, Test, Osteocalcin
Applicant ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
ContactKay A Taylor
CorrespondentKay A Taylor
ROCHE DIAGNOSTICS CORP. 9115 HAGUE RD. Indianapolis,  IN  46250
Product CodeNEO  
Subsequent Product CodeJIT
Subsequent Product CodeJJX
CFR Regulation Number862.1050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-05-18
Decision Date2005-09-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04015630940462 K051297 000
04015630939084 K051297 000

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