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510(k) K961586

URIC ACID-SL ASSAY CATALOGUE NO. 237-60 by Diagnostic Chemicals , Ltd. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 23, 1996
Date Received
April 24, 1996
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

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  • 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)
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