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510(k) K781899

UREA NITROGEN TEST by Wako Intl., Inc. — Product Code CDL

K781899 is an FDA 510(k) premarket notification submitted by Wako Intl., Inc. for the device "UREA NITROGEN TEST". The FDA issued a decision of Substantially Equivalent on December 20, 1978. The device falls under product code CDL (Berthelot Indophenol, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Wako Intl., Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
November 13, 1978
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 Wako Intl., Inc.

  • K790768 — WAKO CHOLESTEROL TEST (May 23, 1979)
  • K781629 — SERI-SEP SERUM/PLASMA ISLOLATOR (October 27, 1978)
  • K781342 — GLUCOSE TEST (August 31, 1978)

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)
  • 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)

FDA data resources