ROM PLUS
FDA 510(k) clearance K110605 · decided 2011-11-23
Clearance details
- K-number
- K110605
- Device name
- ROM PLUS
- Applicant
- Clinical Innovations, LLC
- Decision
- Substantially Equivalent
- Date received
- 2011-03-02
- Decision date
- 2011-11-23
- Days to decision
- 266 days
- Clearance type
- Traditional
- Product code
- NQM
- Device class
- 1
- Regulation number
- 862.1550
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Murray, UT, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AMNISURE FETAL MEMBRANES RUPTURE TEST, MODEL FMRT-1 (K081767) | Amnisure International, LLC | 2009-01-09 |
Recalls involving this device
No recalls on record reference this clearance.