Panels › Clinical Chemistry › Product code CDM · Class 1
Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)
Regulation 862.1785
0510(k)s in 12 months (9 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in CDM
| Company | 510(k)s | Recalls |
|---|---|---|
| Miles Laboratories, Inc. | 2 | 0 |
| Acon Laboratories Co. | 1 | 0 |
| Arj Medical, Inc. | 1 | 0 |
| Boditestor | 1 | 0 |
| California Immuno Diagnostic, Inc. | 1 | 0 |
| Clarity Diagnostics Llc | 0 | 1 |
| Mach Diag. C/O Wichita State University | 1 | 0 |
| Patton, Boggs & Blow | 1 | 0 |
| Wako Chemicals USA, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 5, 2006 | K052719 | URITEST 10 URINALYSIS REAGENT STRIPS Arj Medical, Inc. | CDM |
| Aug 11, 2006 | K061559 | ACON URINALYSIS REAGENT STRIPS Acon Laboratories Co. | CDM |
| May 31, 1988 | K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C Mach Diag. C/O Wichita State University | CDM |
| Jan 21, 1988 | K873366 | WAKO(TM) PRETEST 5A Wako Chemicals USA, Inc. | CDM |
| Sep 3, 1985 | K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE Miles Laboratories, Inc. | CDM |
| Aug 16, 1983 | K830340 | FITKIT I CHECKUP KIT Boditestor | CDM |
| Aug 16, 1983 | K821799 | FITKIT I CHECKUP KIT Patton, Boggs & Blow | CDM |
| Jul 28, 1983 | K831623 | DIA STRIPS SYSTEM California Immuno Diagnostic, Inc. | CDM |
| Jun 28, 1979 | K790965 | REAGENT STRIPS FOR URINALYSIS Miles Laboratories, Inc. | CDM |
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