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510(k) K943002

URIC ACID QVET by Prisma Systems — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 2, 1994
Date Received
June 23, 1994
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 Prisma Systems

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  • K943027 — CHOLESTEROL QVET (January 27, 1995)
  • K942964 — LACTATE DEHYDROGENASE QVET (December 29, 1994)
  • K943042 — BUN QVET (December 29, 1994)
  • K942963 — GLUCOSE QVET (December 29, 1994)
  • K943001 — MAGNESIUM QVET (December 29, 1994)
  • K942997 — ALKALINE PHOSPHATASE (ALKP) QVET (December 29, 1994)
  • K944102 — AST QVET (December 13, 1994)
  • K943000 — ALBUMIN QVET (December 13, 1994)
  • K943026 — POTASSIUM QVET (December 9, 1994)

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  • 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)