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510(k) K011649

RANDOX VALPROIC ACID by Randox Laboratories, Ltd. — Product Code LEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 2002
Date Received
May 29, 2001
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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  • K042476 — VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT (December 1, 2004)
  • K032049 — ROCHE ONLINE TDM VALPROIC ACID (August 22, 2003)
  • K031870 — SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (July 15, 2003)
  • K030405 — QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (April 28, 2003)
  • K011947 — EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (July 2, 2001)
  • 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)