1
/
of
0
FDA 510(k), K162895, Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
FDA 510(k), K162895, Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K162895
Device Name: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
Manufacturer: Roche Diagnostics
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 10/17/2016
Decision Date: 01/18/2017
Regulation Medical Specialty: Clinical Chemistry
Device Name: Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 5
Manufacturer: Roche Diagnostics
Device Classification Name: immunoassay method, troponin subunit
Regulation Number: 862.1215
Classification Product Code: MMI
Date Received: 10/17/2016
Decision Date: 01/18/2017
Regulation Medical Specialty: Clinical Chemistry
Couldn't load pickup availability
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
View full details