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510(k) K042476

VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS by Ortho-Clinical Diagnostics, Inc. — Product Code LEG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 2004
Date Received
September 13, 2004
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

  • K090358 — ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODE (August 6, 2009)
  • K060690 — ONLINE VALPROIC ACID (August 8, 2006)
  • K042807 — ADVIA IMS VALPROIC ACID METHOD (February 8, 2005)
  • 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)
  • K011649 — RANDOX VALPROIC ACID (January 15, 2002)
  • 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)