Panels › Clinical Chemistry › Product code CDN · Class 2
Urease, Photometric, Urea Nitrogen
Regulation 862.1770
0510(k)s in 12 months (16 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in CDN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho-Clinical Diagnostics, Inc. | 2 | 1 |
| Alfa Wassermann Diagnostic Technologies, Inc. | 2 | 0 |
| Alfa Wassermann Diagnostics Technologies, LLC | 1 | 0 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Cholestech Corp. | 1 | 0 |
| Coulter Electronics, Inc. | 1 | 0 |
| The Dow Chemical Co. | 1 | 0 |
| Em Diagnostic Systems, Inc. | 1 | 0 |
| Hitachi Chemical Diagnostics, Inc. | 1 | 0 |
| Instrumentation Laboratory CO | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 27, 2025 | Mckesson Medical-Surgical Inc. Corporate Office ORTHO CLINICAL DIAGNOSTICS INC VITROS BUN (60/CR 5CR/PK) ORCLNL REAGENT. Open, Classified |
CDN | K001885 |
| Nov 15, 2013 | Ortho-Clinical Diagnostics VITROS Chemistry Products BUN/UREA Slides packaged as 300 slides/pack catalog number 8102204
VITROS BUN/UREA Slides quantitatively measure urea concentration, reported either as urea nitrogen (BUN) o Terminated |
CDN | K001885 K961196 |
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