URI-VAL
FDA 510(k) clearance K843680 · decided 1985-03-29
Clearance details
- K-number
- K843680
- Device name
- URI-VAL
- Applicant
- Cenogenics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-18
- Decision date
- 1985-03-29
- Days to decision
- 192 days
- Clearance type
- Traditional
- Product code
- JMZ
- Device class
- 1
- Regulation number
- 862.1540
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Morganville, NJ, 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 |
|---|---|---|
| OSMOLARITY STANDARDS (K844589) | Rna Medical Corp. | 1985-03-01 |
Recalls involving this device
No recalls on record reference this clearance.