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 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 24, 2018 | Clarity Diagnostics Llc Clarity Urocheck 10SG Urinalysis Strips, Model # DTG-10SG
Product Usage:
Clarity 10SG Urinalysis Reagent Strips (Urine) are for the qualitative and semi-quantitative detection of the following analyt Terminated |
CDM | K061559 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.