Uritest 10 Urinalysis Reagent Strips
FDA 510(k) K052719 · Arj Medical, Inc.
510(k) numberK052719
Submission
- Device name
- Uritest 10 Urinalysis Reagent Strips
- Applicant
- Arj Medical, Inc.
Oldsmar, FL, US - Received
- September 29, 2005
- Decision date
- December 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CDM – Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1785
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CDM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K061559 | Acon Urinalysis Reagent StripsCDM · Traditional | Acon Laboratories Co. | 08/11/2006SE |
| K880584 | Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8CCDM · Traditional | Mach Diag. C/O Wichita State University | 05/31/1988SE |
| K873366 | Wako(Tm) Pretest 5ACDM · Traditional | Wako Chemicals USA, Inc. | 01/21/1988SE |
| K852611 | Test Urobilinogen in Urine & Leukocytes in UrineCDM · Traditional | Miles Laboratories, Inc. | 09/03/1985SE |
| K830340 | Fitkit I Checkup KitCDM · Traditional | Boditestor | 08/16/1983SE |
| K821799 | Fitkit I Checkup KitCDM · Traditional | Patton, Boggs & Blow | 08/16/1983SE |
| K831623 | Dia Strips SystemCDM · Traditional | California Immuno Diagnostic, Inc. | 07/28/1983SE |
| K790965 | Reagent Strips for UrinalysisCDM · Traditional | Miles Laboratories, Inc. | 06/28/1979SE |
More from Miles Laboratories, Inc.
Questions and answers
When was Uritest 10 Urinalysis Reagent Strips cleared by the FDA?
Uritest 10 Urinalysis Reagent Strips (K052719) received a 510(k) decision of Substantially Equivalent on December 5, 2006, 432 days after the submission was received.
What is the product code of K052719?
The FDA product code is CDM – Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1785.