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510(k) K964442

VALPROIC ACID ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM by Bayer Corp. — Product Code LEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1996
Date Received
November 6, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Immunoassay, Valproic Acid
Device Class
Class II
Regulation Number
862.3645
Review Panel
TX
Submission Type

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Other clearances for product code LEG

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  • K030405 — QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (April 28, 2003)
  • K011649 — RANDOX VALPROIC ACID (January 15, 2002)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
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