REAGENT STRIPS FOR URINALYSIS
FDA 510(k) clearance K790965 · decided 1979-06-28
Clearance details
- K-number
- K790965
- Device name
- REAGENT STRIPS FOR URINALYSIS
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-05-22
- Decision date
- 1979-06-28
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- CDM
- Device class
- 1
- Regulation number
- 862.1785
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, 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 |
|---|---|---|
| URITEST 10 URINALYSIS REAGENT STRIPS (K052719) | Arj Medical, Inc. | 2006-12-05 |
| ACON URINALYSIS REAGENT STRIPS (K061559) | Acon Laboratories Co. | 2006-08-11 |
| URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C (K880584) | Mach Diag. C/O Wichita State University | 1988-05-31 |
| WAKO(TM) PRETEST 5A (K873366) | Wako Chemicals USA, Inc. | 1988-01-21 |
| TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE (K852611) | Miles Laboratories, Inc. | 1985-09-03 |
| FITKIT I CHECKUP KIT (K821799) | Patton, Boggs & Blow | 1983-08-16 |
| FITKIT I CHECKUP KIT (K830340) | Boditestor | 1983-08-16 |
| DIA STRIPS SYSTEM (K831623) | California Immuno Diagnostic, Inc. | 1983-07-28 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |