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510(k) K110605

ROM PLUS by Clinical Innovations, LLC — Product Code NQM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2011
Date Received
March 2, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Immunoassay For Detection Of Amniotic Fluid Protein(S).
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

The test is for use by health care professionals to aid in the detection of fetal membrane rupture in pregnant women, when they report signs, symptoms or complaints suggestive of such rupture.

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