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510(k) K863076

UREAFAST by J. D. Assoc. — Product Code CDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Berthelot Indophenol, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by J. D. Assoc.

  • K863103 — PEG 6,000 (January 13, 1987)
  • K863054 — AST S.C.E. (GOT) (January 13, 1987)
  • K863069 — MAGNESIOMETER (December 31, 1986)
  • K863079 — CREATINKINETIC (December 12, 1986)
  • K863068 — LDH S.C.E. (December 10, 1986)
  • K863112 — PROTEINMETER (December 10, 1986)
  • K863053 — ALT S.C.E. (GPT) (December 10, 1986)
  • K863066 — TRANSFERMETER (December 4, 1986)
  • K863056 — BILIRUBIN TOTAL (November 24, 1986)
  • K863109 — FERROFAST (November 24, 1986)

Other clearances for product code CDL

  • K896845 — RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT (February 16, 1990)
  • K893128 — STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010 (July 25, 1989)
  • K871651 — COLORIMETRIC BUN REAGENT KIT (May 12, 1987)
  • K864742 — UREA NITROGEN(BUN), COLORIMETRIC METHOD (January 13, 1987)
  • K863889 — UREA NITROGEN TEST (November 24, 1986)
  • K860154 — BUN (ENZYMATIC BERTHELOT) REAGENT SET (February 6, 1986)
  • K831414 — COLORIMETRIC BUN (June 16, 1983)
  • K822237 — UREA NITROGEN REAGENT SET (MOD. BERTHEL (August 16, 1982)
  • K810261 — EUROCHIMA UREA NITROGEN (February 10, 1981)
  • K801727 — DATA-ZYME UREA NITROGEN, COLORIMETRIC (September 9, 1980)