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510(k) K110605

Device
ROM PLUS
Applicant
CLINICAL INNOVATIONS, LLC
510(k) number
K110605
Product code
NQM  
Decision
Substantially Equivalent (SESE)
Decision date
2011-11-23
Date received
2011-03-02
Regulation
862.1550
Classification name
Immunoassay For Detection Of Amniotic Fluid Protein(s).
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DEAN WALLACE
Address
747 W 4170 S Murray UT US 84123 84123

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NQM  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K081767AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1Amnisure International, LLC2009-01-09

Legacy Summary#

summary

FDA Review#

Decision Summary