Product code CDN— Clinical Chemistry
ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- Classification name
- Urease, Photometric, Urea Nitrogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1770
- Advisory panel
- Clinical Chemistry
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code CDN
FDA has cleared devices under product code CDN between 1977 and 2019, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2019
- 2013
- 2012
- 2011
- 2000
- 1997
- 1996
- 1994
- 1992
- 1991
- 1982
- 1980
- 1979
- 1978
- 1977
Top applicants under product code CDN
- Ortho-Clinical Diagnostics, Inc.
- Alfa Wassermann Diagnostic Technologies, Inc.
- The Dow Chemical Co.
- Prisma Systems
- Nobel Scientific Industries, Inc.
- King Diagnostics, Inc.
- Johnson & Johnson Clinical Diagnostics, Inc.
- Instrumentation Laboratory CO
- Hitachi Chemical Diagnostics, Inc.
- Em Diagnostic Systems, Inc.
Recent clearances under product code CDN
- K190326 — VITROS XT Chemistry Products UREA-CREA Slides
- K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE
- K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAGENT
- K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT
- K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANIC PHOSPHORUS U.V. REAGENT,URINE STANDARD
- K001885 — VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 1
- K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM
- K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA)
- K943042 — BUN QVET
- K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT
- K914903 — QUICKSTART UREA NITROGEN
- K822154 — UREA NITROGEN (ENZYMATIC) DETERMINATION
- K802518 — BUN REAGENT ASTRA 4 & 8 ANALYZERS
- K792328 — STATTEK BUN
- K781253 — BUN (UREASE) REAGENT
- K771442 — MULTISTAT III UREA NITROGEN TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.