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510(k) K812313

SANDARE URIC ACID PROCEDURE by Sandare Chemical Co., Inc. — Product Code LFQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 1, 1981
Date Received
August 17, 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 Sandare Chemical Co., Inc.

  • K872852 — EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TEST (September 29, 1987)
  • K862556 — SANDARE GLYCOHEMOGLOBIN PROCEDURE (August 8, 1986)
  • K860684 — SANDARE BCG ALBUMIN PROCEDURE (March 17, 1986)
  • K851395 — SANDARE IRON-BINDING CAPACITY PROCEDURE (May 7, 1985)
  • K851394 — SANDARE IRON PROCEDURE (April 30, 1985)
  • K844498 — SANDARE ALKALINE PHOSPHATASE PROCEDURE (December 10, 1984)
  • K842516 — SANDARE ACID PHOSPHATASE PROCEDURE (August 17, 1984)
  • K833898 — TRI-LEVEL BILIRUBIN CONTROLS (January 13, 1984)
  • K832942 — TOTAL & DIRECT BILIRUBIN PROCEDURES (November 7, 1983)
  • K832632 — ALBUMIN PROCEDURE BCP (September 12, 1983)

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)
  • K811764 — URIC ACID REAGENT SET (August 20, 1981)