Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8C
FDA 510(k) K880584 · Mach Diag. C/O Wichita State University
510(k) numberK880584
Submission
- Device name
- Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8C
- Applicant
- Mach Diag. C/O Wichita State University
Wichita, KS, US - Received
- February 10, 1988
- Decision date
- May 31, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K052719 | Uritest 10 Urinalysis Reagent StripsCDM · Traditional | Arj Medical, Inc. | 12/05/2006SE |
| K061559 | Acon Urinalysis Reagent StripsCDM · Traditional | Acon Laboratories Co. | 08/11/2006SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K880585 | Dexpad, Blood Glucose StripCGA · Traditional | 04/18/1988SE |
Questions and answers
When was Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8C cleared by the FDA?
Uri-Chem(R) GK,2,3,4C,5CN,6C,7C and 8C (K880584) received a 510(k) decision of Substantially Equivalent on May 31, 1988, 111 days after the submission was received.
What is the product code of K880584?
The FDA product code is CDM – Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1785.