1
/
of
0
FDA 510(k), K110605, ROM PLUS
FDA 510(k), K110605, ROM PLUS
Regular price
$149.00 USD
Regular price
Sale price
$149.00 USD
Unit price
/
per
510(K) Number: K110605
Device Name: ROM PLUS
Manufacturer: CLINICAL INNOVATIONS, LLC
Device Classification Name: immunoassay for detection of amniotic fluid protein(s).
Regulation Number: 862.1550
Classification Product Code: NQM
Date Received: 03/02/2011
Decision Date: 11/23/2011
Regulation Medical Specialty: Clinical Chemistry
Device Name: ROM PLUS
Manufacturer: CLINICAL INNOVATIONS, LLC
Device Classification Name: immunoassay for detection of amniotic fluid protein(s).
Regulation Number: 862.1550
Classification Product Code: NQM
Date Received: 03/02/2011
Decision Date: 11/23/2011
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