FITKIT I CHECKUP KIT
FDA 510(k) clearance K830340 · decided 1983-08-16
Clearance details
- K-number
- K830340
- Device name
- FITKIT I CHECKUP KIT
- Applicant
- Boditestor
- Decision
- Substantially Equivalent
- Date received
- 1983-02-02
- Decision date
- 1983-08-16
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- CDM
- Device class
- 1
- Regulation number
- 862.1785
- 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 |
|---|---|---|
| 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 |
| DIA STRIPS SYSTEM (K831623) | California Immuno Diagnostic, Inc. | 1983-07-28 |
| REAGENT STRIPS FOR URINALYSIS (K790965) | Miles Laboratories, Inc. | 1979-06-28 |
Recalls involving this device
No recalls on record reference this clearance.