Home / 510(k) Clearances / K781306

510(k) K781306

UREA NITROGEN TEST KIT by Analytical & Research Chemicals, Inc. — Product Code CDL

K781306 is an FDA 510(k) premarket notification submitted by Analytical & Research Chemicals, Inc. for the device "UREA NITROGEN TEST KIT". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code CDL (Berthelot Indophenol, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Analytical & Research Chemicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1978
Date Received
July 28, 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 Analytical & Research Chemicals, Inc.

  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781324 — ALP TEST (August 31, 1978)
  • K781309 — GOT PROCEDURE (August 31, 1978)
  • K781305 — UREA NITROGEN (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)
  • K781308 — GLUCOLOUR (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