510(k) K110605
K110605 is an FDA 510(k) premarket notification submitted by Clinical Innovations, LLC for the device "ROM PLUS". The FDA issued a decision of Substantially Equivalent on November 23, 2011. The device falls under product code NQM (Immunoassay For Detection Of Amniotic Fluid Protein(S).), a Class I device regulated under 21 CFR 862.1550. Clinical Innovations, LLC has at least 10 other 510(k) clearances on record.
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.