FDA Product Code
FDA Product Code CDM — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1785
510(k) Clearances — 9 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K052719 | URITEST 10 URINALYSIS REAGENT STRIPS | Arj Medical, Inc. | 2006-12-05 | Traditional | PDF ↗ |
| K061559 | ACON URINALYSIS REAGENT STRIPS | Acon Laboratories Co. | 2006-08-11 | Traditional | PDF ↗ |
| K880584 | URI-CHEM(R) GK,2,3,4C,5CN,6C,7C AND 8C | Mach Diag. C/O Wichita State University | 1988-05-31 | Traditional | PDF ↗ |
| K873366 | WAKO(TM) PRETEST 5A | Wako Chemicals USA, Inc. | 1988-01-21 | Traditional | PDF ↗ |
| K852611 | TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE | Miles Laboratories, Inc. | 1985-09-03 | Traditional | PDF ↗ |
| K821799 | FITKIT I CHECKUP KIT | Patton, Boggs & Blow | 1983-08-16 | Traditional | PDF ↗ |
| K830340 | FITKIT I CHECKUP KIT | Boditestor | 1983-08-16 | Traditional | PDF ↗ |
| K831623 | DIA STRIPS SYSTEM | California Immuno Diagnostic, Inc. | 1983-07-28 | Traditional | PDF ↗ |
| K790965 | REAGENT STRIPS FOR URINALYSIS | Miles Laboratories, Inc. | 1979-06-28 | Traditional | PDF ↗ |
Product code CDM · Class I · Clinical Chemistry. Data: openFDA.