Home / 510(k) Clearances / K864742

510(k) K864742

UREA NITROGEN(BUN), COLORIMETRIC METHOD by Tech-Co, Inc. — Product Code CDL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 1987
Date Received
December 4, 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 Tech-Co, Inc.

  • K921968 — IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TEST (June 28, 1996)
  • K923376 — VISUAL HCG PREGNANCY TEST (October 1, 1992)
  • K920766 — T4 EIA BEAD ASSAY (April 17, 1992)
  • K920716 — DIRECT PREGNANCY TEST (March 24, 1992)
  • K902574 — POTASSIUM REAGENT SET (July 10, 1990)
  • K901561 — IRON/TOTAL IRON BINDING CAPACITY (May 17, 1990)
  • K883387 — ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (October 13, 1988)
  • K883386 — CHLORIDE (October 6, 1988)
  • K883683 — HEMOGLOBIN (October 6, 1988)
  • K881172 — BILIRUBIN (DIRECT) (June 7, 1988)

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)
  • K863889 — UREA NITROGEN TEST (November 24, 1986)
  • K863076 — UREAFAST (September 9, 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)