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510(k) K922969

KING DIAGNOSTICS UREA NITROGEN REAGENT by King Diagnostics, Inc. — Product Code CDN

K922969 is an FDA 510(k) premarket notification submitted by King Diagnostics, Inc. for the device "KING DIAGNOSTICS UREA NITROGEN REAGENT". The FDA issued a decision of Substantially Equivalent on October 13, 1992. The device falls under product code CDN (Urease, Photometric, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. King Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1992
Date Received
June 19, 1992
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 King Diagnostics, Inc.

  • K933329 — KING DIAGNOSTICS IRON AND TOTAL IRON BINDING CAPACITY REAGENT (October 22, 1993)
  • K931834 — KING SODIUM/POTASSIUM STANDARD MODIFIED (August 25, 1993)
  • K931773 — HDL PRECIPITATING REAGENT (DEXTRAN SULFATE) (August 16, 1993)
  • K931326 — KING DIAGNOSTICS CK REAGENT (June 15, 1993)
  • K923129 — KING DIAGNOSTICS GLUCOSE (HK) REAGENT (November 2, 1992)
  • K922921 — KING DIAGNOSTICS CHLORIDE REAGENT (October 5, 1992)
  • K923927 — KING DIAGNOSTICS MAGNESIUM REAGENT (September 30, 1992)
  • K923091 — KING DIAGNOSTICS GAMMA GT REAGENT (September 9, 1992)
  • K923128 — KING DIAGNOSTICS CHOLESTEROL REAGENT (September 9, 1992)
  • K922964 — KING DIAGNOSTIC TRIGLYCERIDES REAGENT (August 18, 1992)

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)
  • K972012 — CHOLESTECH BUN/CREATININE TEST SYSTEM (July 24, 1997)
  • K961196 — EKTACHEM CLINICAL CHEMISTRY UREA NITROGEN/UREA (BUN/UREA) (May 15, 1996)
  • K943042 — BUN QVET (December 29, 1994)
  • K914903 — QUICKSTART UREA NITROGEN (December 31, 1991)

FDA data resources