AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
FDA 510(k) clearance K030849 · decided 2004-02-02
Clearance details
- K-number
- K030849
- Device name
- AMNISURE FETAL MEMBRANES RUPTURE TEST MODEL FMRT1
- Applicant
- N-Dia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-03-17
- Decision date
- 2004-02-02
- Days to decision
- 322 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| AmniSure ROM Test, Fetal Membrane Rupture Test for In-Vitro Diagnostic Use, Model: FMRT-1, recall (Z-0120-2008) | AmniSure International LLC | 2008-01-19 |