BIOSCAN REAGENT STRIPS
FDA 510(k) clearance K943008 · decided 1994-08-08
Clearance details
- K-number
- K943008
- Device name
- BIOSCAN REAGENT STRIPS
- Applicant
- Genesis Labs, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-06-24
- Decision date
- 1994-08-08
- Days to decision
- 45 days
- Clearance type
- Traditional
- Product code
- JJB
- Device class
- 1
- Regulation number
- 862.1115
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Edina, MN, 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 |
| 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.