Urease, Photometric, Urea Nitrogen
The Urease Photometric Urea Nitrogen Test is a clinical chemistry device that measures blood urea nitrogen (BUN) by enzymatic hydrolysis of urea with urease, followed by photometric detection of the resulting ammonia, used to evaluate kidney function and nitrogen balance. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is CDN, regulated under 21 CFR 862.1770, within the Clinical Chemistry medical specialty. This device is eligible for third-party review.
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Basic Information
- Product Code
- CDN
- Device Class
- FDA class 2
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K190326 | VITROS XT Chemistry Products UREA-CREA Slides | Mar 14, 2019 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K132462 | S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE | Oct 28, 2013 | Substantially Equivalent | Hitachi Chemical Diagnostics, Inc. |
| K123322 | ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT | May 21, 2013 | Substantially Equivalent | Alfa Wassermann Diagnostics Technologies, LLC |
| K113389 | ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT | Aug 10, 2012 | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. |
| K103615 | ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD | Sep 08, 2011 | Substantially Equivalent | Alfa Wassermann Diagnostic Technologies, Inc. |
| K001885 | VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1 | Jul 20, 2000 | Substantially Equivalent | Ortho-Clinical Diagnostics, Inc. |
| K972012 | CHOLESTECH BUN/CREATININE TEST SYSTEM | Jul 24, 1997 | Substantially Equivalent | Cholestech Corp. |
| K961196 | EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) | May 15, 1996 | Substantially Equivalent | Johnson & Johnson Clinical Diagnostics, Inc. |
| K943042 | BUN QVET | Dec 29, 1994 | Substantially Equivalent | Prisma Systems |
| K922969 | KING DIAGNOSTICS UREA NITROGEN REAGENT | Oct 13, 1992 | Substantially Equivalent | King Diagnostics, Inc. |
| K914903 | QUICKSTART UREA NITROGEN | Dec 31, 1991 | Substantially Equivalent | Em Diagnostic Systems, Inc. |
| K822154 | UREA NITROGEN (ENZYMATIC) DETERMINATION | Aug 05, 1982 | Substantially Equivalent | The Dow Chemical Co. |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nov 12, 1980 | Substantially Equivalent | Nobel Scientific Industries, Inc. |
| K792328 | STATTEK BUN | Dec 18, 1979 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K781253 | BUN (UREASE) REAGENT | Aug 21, 1978 | Substantially Equivalent | Coulter Electronics, Inc. |
| K771442 | MULTISTAT III UREA NITROGEN TEST | Aug 22, 1977 | Substantially Equivalent | Instrumentation Laboratory CO |
FEI Numbers
This FDA classification entry is associated with 9 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 9 registration numbers. Click on an entry to view related FDA registrations.