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510(k) K031870

SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT by Beckman Coulter, Inc. — Product Code LEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 15, 2003
Date Received
June 17, 2003
Clearance Type
Special
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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  • K032049 — ROCHE ONLINE TDM VALPROIC ACID (August 22, 2003)
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  • K002551 — EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019U (October 11, 2000)
  • K000005 — IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2 (March 3, 2000)