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510(k) K972012

CHOLESTECH BUN/CREATININE TEST SYSTEM by Cholestech Corp. — Product Code CDN

K972012 is an FDA 510(k) premarket notification submitted by Cholestech Corp. for the device "CHOLESTECH BUN/CREATININE TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on July 24, 1997. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Cholestech Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1997
Date Received
May 30, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Urease, Photometric, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Cholestech Corp.

  • K040579 — CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP) (June 18, 2004)
  • K032027 — CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST) (September 5, 2003)
  • K991834 — CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 (September 9, 1999)
  • K954778 — CHOLESTECH LDX SYSTEM (November 24, 1995)
  • K946064 — TOTAL CHOLESTEROL CASSETTE (February 22, 1995)
  • K946067 — TOTAL CHOLESTEROL, HDL CHOLESTEROL, TRIGLYCERIDES AND GLUCOSE PANEL (February 22, 1995)
  • K946066 — TOTAL CHOLESTEROL, HDL CHOLESTEROL AND GLUCOSE PANEL (February 22, 1995)
  • K946063 — TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL (February 22, 1995)
  • K946065 — TOTAL CHOLESTEROLM HDL CHOLESTEROL AND TRIGLYCERIDES PANEL (February 22, 1995)
  • K932727 — CHOLESTECH L.D.X. SYSTEM (November 9, 1993)

Other clearances for product code CDN

  • K190326 — VITROS XT Chemistry Products UREA-CREA Slides (March 14, 2019)
  • K132462 — S TEST REAGENT CARTRIDGE BUN AND S TEST REAGENT CARTRIDGE CRE (October 28, 2013)
  • K123322 — ACE BUN/UREA REAGENT, ACE CREATININE REAGENT, ACE URIC ACID REAGENT, ACE CK REAG (May 21, 2013)
  • K113389 — ACE CK REAGENT,ACE BUN/UREA REAGENT,ACE URIC ACID REAGENT,ACE CREATININE REAGENT (August 10, 2012)
  • K103615 — ACE UREA NITROGEN REAGENT, CALCIUM-ARSEAZO REAGENT, CREATININE REAGENT, INORGANI (September 8, 2011)
  • K001885 — VITROS CHEMISTRY PRODUCTS BUN/UREA SLIDES AND VITROS CHEMISTRY PRODUCTS CALIBRAT (July 20, 2000)
  • K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (May 15, 1996)
  • K943042 — BUN QVET (December 29, 1994)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)
  • K914903 — QUICKSTART UREA NITROGEN (December 31, 1991)

FDA data resources