Home / 510(k) Clearances / K781305

510(k) K781305

UREA NITROGEN by Analytical & Research Chemicals, Inc. — Product Code CDW

K781305 is an FDA 510(k) premarket notification submitted by Analytical & Research Chemicals, Inc. for the device "UREA NITROGEN". The FDA issued a decision of Substantially Equivalent on August 31, 1978. The device falls under product code CDW (Diacetyl-Monoxime, 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
Diacetyl-Monoxime, Urea Nitrogen
Device Class
Class II
Regulation Number
862.1770
Review Panel
CH
Submission Type

Other clearances by Analytical & Research Chemicals, Inc.

  • K823784 — ENZYMATIC CHOLESTEROL (COLORIMETRIC (January 14, 1983)
  • K823786 — ALKALINE PHOSPHATASE (January 14, 1983)
  • K823806 — DIRECT CREATININE PROCEDURE (January 14, 1983)
  • K781460 — CHLORIDE REAGENT (October 10, 1978)
  • K781441 — BCG ALBUMIN REAGET (October 10, 1978)
  • K781309 — GOT PROCEDURE (August 31, 1978)
  • K781323 — LDH PROCEDURE (August 31, 1978)
  • K781324 — ALP TEST (August 31, 1978)
  • K781306 — UREA NITROGEN TEST KIT (August 31, 1978)
  • K781307 — GLUCOSE DETERM. KIT (August 31, 1978)

Other clearances for product code CDW

  • K874532 — BLOOD UREA NITROGEN (January 5, 1988)
  • K871320 — FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814 (April 22, 1987)
  • K863425 — AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346 (October 1, 1986)
  • K861775 — TWIN BUN/GLUCOSE (June 27, 1986)
  • K860419 — UREA NITROGEN REAGENT SET (February 11, 1986)
  • K850937 — UREA (June 10, 1985)
  • K844156 — UREA NITROGEN REAGENT SET (November 13, 1984)
  • K841068 — UREA NITROGEN REAGENT SET (May 1, 1984)
  • K822323 — ULTRACHEM BUN-UV, 65080 & 65081 (September 2, 1982)
  • K821212 — UREA NITROGEN REAGENT SET (July 22, 1982)

FDA data resources