URINE REAGENT STRIPS-8 PARAMETERS
FDA 510(k) clearance K943436 · decided 1995-04-24
Clearance details
- K-number
- K943436
- Device name
- URINE REAGENT STRIPS-8 PARAMETERS
- Applicant
- Teco Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 1994-07-18
- Decision date
- 1995-04-24
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- JJB
- Device class
- 1
- Regulation number
- 862.1115
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Placentia, CA, 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 |
|---|---|---|
| BIOSCAN REAGENT STRIPS (K943008) | Genesis Labs, Inc. | 1994-08-08 |
| WAKO(TM) PRETEST 8A (K873553) | Wako Chemicals USA, Inc. | 1987-09-22 |
| URINE DIAGNOSTIC REAGENT STRIPS (K862806) | Amatech International, Inc. | 1986-12-04 |
| REAGENT TESTS STRIP COMBINATIONS (K833521) | Syn-Kit, Inc. | 1984-01-11 |
Recalls involving this device
No recalls on record reference this clearance.