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510(k) K813415

UREA NITROGEN REAGENT SET by Anco Medical Reagents & Assoc. — Product Code CDW

K813415 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "UREA NITROGEN REAGENT SET". The FDA issued a decision of Substantially Equivalent on December 31, 1981. The device falls under product code CDW (Diacetyl-Monoxime, Urea Nitrogen), a Class II device regulated under 21 CFR 862.1770. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1981
Date Received
December 7, 1981
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 Anco Medical Reagents & Assoc.

  • K842440 — SICKLE CELL STAT A/S HETEROZYGOUS-ERYTH (July 27, 1984)
  • K831871 — SICKLE-HEME A/S CONTROLS & A/A CONTROL (July 28, 1983)
  • K821658 — HEMOGLOBIN REAGENT (June 25, 1982)
  • K821526 — ACID PHOSPHATASE REAGENT SET (June 10, 1982)
  • K821102 — MEGNESIUM REAGENT KIT (May 5, 1982)
  • K820951 — ENZYMATIC CHOLESTEROL KIT (April 26, 1982)
  • K820466 — SGOT REAGENT SET (March 11, 1982)
  • K820491 — SGPT REAGENT SET (March 11, 1982)
  • K820500 — TOTAL LIPID REAGENT SET (March 11, 1982)
  • K812837 — ALKALINE PHOSPHATASE REAGENT SET (January 29, 1982)

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