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510(k) K842103

TOYO JOZO URIC ACID TEST by Advocacy International, Ltd. — Product Code KNK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 1984
Date Received
May 25, 1984
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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  • K993469 — WAKO L-TYPE UA F TEST (November 9, 1999)
  • K991247 — URIC ACID, MODEL UA112-01 (May 25, 1999)