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 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 14, 2019 | K190326 | VITROS XT Chemistry Products UREA-CREA Slides Ortho-Clinical Diagnostics, Inc. | CDN |
| Oct 28, 2013 | K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE Hitachi Chemical Diagnostics, Inc. | CDN |
| May 21, 2013 | K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT Alfa Wassermann Diagnostics Technologies, LLC | CDN |
| Aug 10, 2012 | K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT Alfa Wassermann Diagnostic Technologies, Inc. | CDN |
| Sep 8, 2011 | K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD Alfa Wassermann Diagnostic Technologies, Inc. | CDN |
| Jul 20, 2000 | K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 Ortho-Clinical Diagnostics, Inc. | CDN |
| Jul 24, 1997 | K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM Cholestech Corp. | CDN |
| May 15, 1996 | K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) Johnson & Johnson Clinical Diagnostics, Inc. | CDN |
| Dec 29, 1994 | K943042 | BUN QVET Prisma Systems | CDN |
| Oct 13, 1992 | K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT King Diagnostics, Inc. | CDN |
| Dec 31, 1991 | K914903 | QUICKSTART UREA NITROGEN Em Diagnostic Systems, Inc. | CDN |
| Aug 5, 1982 | K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION The Dow Chemical Co. | CDN |
| Nov 12, 1980 | K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS Nobel Scientific Industries, Inc. | CDN |
| Dec 18, 1979 | K792328 | STATTEK BUN Boehringer Mannheim Corp. | CDN |
| Aug 21, 1978 | K781253 | BUN (UREASE) REAGENT Coulter Electronics, Inc. | CDN |
| Aug 22, 1977 | K771442 | MULTISTAT III UREA NITROGEN TEST Instrumentation Laboratory CO | CDN |
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