Dia Strips System
FDA 510(k) K831623 · California Immuno Diagnostic, Inc.
510(k) numberK831623
Submission
- Device name
- Dia Strips System
- Applicant
- California Immuno Diagnostic, Inc.
Walker, MI, US - Received
- May 20, 1983
- Decision date
- July 28, 1983
- 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 |
| 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 |
| K790965 | Reagent Strips for UrinalysisCDM · Traditional | Miles Laboratories, Inc. | 06/28/1979SE |
More from Miles Laboratories, Inc.
Questions and answers
When was Dia Strips System cleared by the FDA?
Dia Strips System (K831623) received a 510(k) decision of Substantially Equivalent on July 28, 1983, 69 days after the submission was received.
What is the product code of K831623?
The FDA product code is CDM – Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1785.