URINE DIAGNOSTIC REAGENT STRIPS
FDA 510(k) clearance K862806 · decided 1986-12-04
Clearance details
- K-number
- K862806
- Device name
- URINE DIAGNOSTIC REAGENT STRIPS
- Applicant
- Amatech International, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-07-23
- Decision date
- 1986-12-04
- Days to decision
- 134 days
- Clearance type
- Traditional
- Product code
- JJB
- Device class
- 1
- Regulation number
- 862.1115
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Houston, TX, 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 |
|---|---|---|
| URINE REAGENT STRIPS-8 PARAMETERS (K943436) | Teco Diagnostics | 1995-04-24 |
| BIOSCAN REAGENT STRIPS (K943008) | Genesis Labs, Inc. | 1994-08-08 |
| WAKO(TM) PRETEST 8A (K873553) | Wako Chemicals USA, Inc. | 1987-09-22 |
| REAGENT TESTS STRIP COMBINATIONS (K833521) | Syn-Kit, Inc. | 1984-01-11 |
Recalls involving this device
No recalls on record reference this clearance.