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510(k) K912028

URIC ACID (URICASE) REAGENT, UNIVERSAL by Enzyme Technology, Inc. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1991
Date Received
May 8, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Uric, Uricase (Colorimetric)
Device Class
Class I
Regulation Number
862.1775
Review Panel
CH
Submission Type

Other clearances by Enzyme Technology, Inc.

  • K912027 — CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL (January 30, 1992)
  • K905227 — GLUCOSE (HK) REAGENT, UNIVERSAL (March 11, 1991)
  • K905226 — TRIGLYCERIDE (GPO) REAGENT, UNIVERSAL (December 11, 1990)
  • K896073 — CHOLESTEROL, UNIVERSAL ET (December 12, 1989)

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  • K040467 — VITALAB URIC ACID REAGENT (March 8, 2004)
  • K031044 — ATAC PAK URIC ACID REAGENT AND ATAC CALIBRATOR (July 15, 2003)
  • K022096 — URIC ACID ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM (March 18, 2003)
  • K023550 — WIENER LAB URICOSTAT ENZIMATICO AA LIQUIDA (December 9, 2002)
  • K012038 — JAS URIC ACID LIQUID REAGENT (August 21, 2001)
  • K010421 — WIENER LAB. URICOSTAT ENZIMATICO AA, MODELS 2X50 ML CATALOGUE NO 1840106 AND 4X5 (April 13, 2001)
  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)