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U.S. Department of Health and Human Services

510(k) Premarket Notification
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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
Correspondent Contact DEAN WALLACE
Regulation Number862.1550
Classification Product Code
NQM  
Subsequent Product Code
JJX  
Date Received03/02/2011
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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