ROM PLUS


Device Classification Name

immunoassay for detection of amniotic fluid protein(s).

510(k) Number K110605
Device Name ROM PLUS
Applicant
CLINICAL INNOVATIONS, LLC
747 west 4170 south
murray, 
UT 
84123

Applicant Contact dean wallace
Correspondent
CLINICAL INNOVATIONS, LLC
747 west 4170 south
murray, 
UT 
84123

Correspodent Contact dean wallace
Regulation Number 862.1550
Classification Product Code
NQM  
Subsequent Product Code
JJX  
Date Received 03/02/2011
Decision Date 11/23/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No