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510(k) K981189

URIC ACID by Abbott Laboratories — Product Code CDO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1998
Date Received
April 2, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K955752 — OLYMPUS URIC ACID REAGENT (January 31, 1996)
  • K932162 — URIC ACID TEST ITEM NUMBER 65422 (September 27, 1993)
  • K923765 — SYSTEMATE URICACID TEST, TECHNICON RA 1000 (September 22, 1992)
  • K903335 — SYSTEMATE URIC ACID (URCA) ITEM NUMBER 65422 (August 17, 1990)
  • K875320 — BIOTROL URIC ACID ENZYMATIQUE UV H.P. (February 1, 1988)