K110605 is an FDA 510(k) clearance for the ROM PLUS. This device is classified as a Immunoassay For Detection Of Amniotic Fluid Protein(s). (Class I - General Controls, product code NQM).
Submitted by Clinical Innovations, LLC (Murray, US). The FDA issued a Cleared decision on November 23, 2011, 266 days after receiving the submission on March 2, 2011.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1550. 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..
| 510(k) Number | K110605 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 02, 2011 |
| Decision Date | November 23, 2011 |
| Days to Decision | 266 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | NQM - Immunoassay For Detection Of Amniotic Fluid Protein(s). |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1550 |
| Definition | 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. |