Rom Plus
FDA 510(k) K110605 · Clinical Innovations, LLC
510(k) numberK110605
Submission
- Device name
- Rom Plus
- Applicant
- Clinical Innovations, LLC
Murray, UT, US - Received
- March 2, 2011
- Decision date
- November 23, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQM – Immunoassay For Detection Of Amniotic Fluid Protein(S).
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1550
- Specialty
- Clinical Chemistry
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.
Other 510(k)s with product code NQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K081767 | Amnisure Fetal Membranes Rupture Test, Model FMRT-1NQM · Traditional | Amnisure International, LLC | 01/09/2009SE |
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| K153591 | ebb Complete Tamponade SystemOQY · Special | 01/14/2016SE |
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| K140163 | Koala TocoHFM · Traditional | 05/29/2014SE |
| K131781 | Clearview TotalLKF · Traditional | 05/28/2014SE |
| K061539 | Gomco Circumcision Clamp, Mogen Clamp, Plastibell Circumcision DeviceHFX · Traditional | 09/20/2007SE |
| K030691 | Fetal Spiral Electrode, Model FSE07000HGP · Traditional | 09/17/2003SE |
| K022023 | Compass Esophageal Pressure Catheter, Model GIE-8500, Compass Ano-Rectal Pressure…KLA · Traditional | 01/07/2003SE |
Questions and answers
When was Rom Plus cleared by the FDA?
Rom Plus (K110605) received a 510(k) decision of Substantially Equivalent on November 23, 2011, 266 days after the submission was received.
What is the product code of K110605?
The FDA product code is NQM – Immunoassay For Detection Of Amniotic Fluid Protein(S)., a Class I (low risk) device regulated under 21 CFR 862.1550.