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510(k) K811764

URIC ACID REAGENT SET by Anco Medical Reagents & Assoc. — Product Code LFQ

K811764 is an FDA 510(k) premarket notification submitted by Anco Medical Reagents & Assoc. for the device "URIC ACID REAGENT SET". The FDA issued a decision of Substantially Equivalent on August 20, 1981. The device falls under product code LFQ (Acid, Uric, Acid Reduction Of Ferric Ion), a Class I device regulated under 21 CFR 862.1775. Anco Medical Reagents & Assoc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1981
Date Received
June 22, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Acid Reduction Of Ferric Ion
Device Class
Class I
Regulation Number
862.1775
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 LFQ

  • K860111 — URIC ACID REAGENT SET (February 19, 1986)
  • K860142 — URIC ACID REAGENT SET (COLORIMETRIC) (February 11, 1986)
  • K844075 — URIC ACID REAGENT SET (October 30, 1984)
  • K812313 — SANDARE URIC ACID PROCEDURE (September 1, 1981)

FDA data resources