ACON URINALYSIS REAGENT STRIPS
FDA 510(k) clearance K061559 · decided 2006-08-11
Clearance details
- K-number
- K061559
- Device name
- ACON URINALYSIS REAGENT STRIPS
- Applicant
- Acon Laboratories Co.
- Decision
- Substantially Equivalent
- Date received
- 2006-06-05
- Decision date
- 2006-08-11
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- CDM
- Device class
- 1
- Regulation number
- 862.1785
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Antonio, TX, US
- Third-party review
- No
- Expedited review
- No
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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 |
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| 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 |
| REAGENT STRIPS FOR URINALYSIS (K790965) | Miles Laboratories, Inc. | 1979-06-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG Product Usage: Clarity 10SG Urin recall (Z-2786-2018) | Clarity Diagnostics Llc | 2018-07-24 |