URITEST 9, INLAB REAGENT STRIPS URINALY
FDA 510(k) clearance K822709 · decided 1983-01-28
Clearance details
- K-number
- K822709
- Device name
- URITEST 9, INLAB REAGENT STRIPS URINALY
- Applicant
- Laprol Scientific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-09-07
- Decision date
- 1983-01-28
- Days to decision
- 143 days
- Clearance type
- Traditional
- Product code
- JMA
- Device class
- 1
- Regulation number
- 862.1095
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| QUANTIMETRIX C-CLEAR(TM) (K931523) | Quantimetrix Corp. | 1993-06-25 |
| HELENA BIOSTRIP A (K830978) | Helena Laboratories | 1983-05-13 |
Recalls involving this device
No recalls on record reference this clearance.