AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
FDA 510(k) clearance K081767 · decided 2009-01-09
Clearance details
- K-number
- K081767
- Device name
- AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1
- Applicant
- Amnisure International, LLC
- Decision
- Substantially Equivalent
- Date received
- 2008-06-20
- Decision date
- 2009-01-09
- Days to decision
- 203 days
- Clearance type
- Traditional
- Product code
- NQM
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cambridge, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AmniSure ROM Test under the following labels: 1) Catalog Number FMRT-1-25 and 2) Catalog N recall (Z-2577-2018) | Qiagen Sciences, Inc. | 2018-07-13 |