Test Urobilinogen in Urine & Leukocytes in Urine
FDA 510(k) K852611 · Miles Laboratories, Inc.
510(k) numberK852611
Submission
- Device name
- Test Urobilinogen in Urine & Leukocytes in Urine
- Applicant
- Miles Laboratories, Inc.
Elkhart, IN, US - Received
- June 19, 1985
- Decision date
- September 3, 1985
- 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 |
| 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 |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Test Urobilinogen in Urine & Leukocytes in Urine cleared by the FDA?
Test Urobilinogen in Urine & Leukocytes in Urine (K852611) received a 510(k) decision of Substantially Equivalent on September 3, 1985, 76 days after the submission was received.
What is the product code of K852611?
The FDA product code is CDM – Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1785.