Home / 510(k) Clearances / K802518

510(k) K802518

BUN REAGENT ASTRA 4 & 8 ANALYZERS by Nobel Scientific Industries, Inc. — Product Code CDN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 15, 1980
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 Nobel Scientific Industries, Inc.

  • K854717 — NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 (January 14, 1986)
  • K854716 — NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 (January 7, 1986)
  • K854718 — NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 (December 19, 1985)
  • K850944 — NSI LYSING-D REAGENT -4000 ML (March 29, 1985)
  • K844782 — NSI ELT-D DILUTING FLUID 4000ML (March 5, 1985)
  • K823283 — FLUSHING SOLUTION (December 3, 1982)
  • K812866 — ASTRA REAGENT CONCENTRATE SYSTEM (December 17, 1981)
  • K810549 — THERMAL PRINTER PAPER (April 8, 1981)
  • K810550 — SILVER ANODE (April 8, 1981)
  • K801346 — NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA (August 12, 1980)

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)
  • K922969 — KING DIAGNOSTICS UREA NITROGEN REAGENT (October 13, 1992)