Atlas FDA

ONLINE VALPROIC ACID

FDA 510(k) clearance K060690 · decided 2006-08-08

Clearance details

K-number
K060690
Device name
ONLINE VALPROIC ACID
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2006-03-15
Decision date
2006-08-08
Days to decision
146 days
Clearance type
Traditional
Product code
LEG
Device class
2
Regulation number
862.3645
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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RecordFirmDate
ARCHITECT IVALPROIC ACID REAGENTS AND ARCHITECT IVALPROIC ACID CALIBRATORS, MODELS 1P35, 1P35 (K090358)Abbott Laboratories, Inc.2009-08-06
ADVIA IMS VALPROIC ACID METHOD (K042807)Bayer Healthcare, LLC2005-02-08
VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS (K042476)Ortho-Clinical Diagnostics, Inc.2004-12-01
ROCHE ONLINE TDM VALPROIC ACID (K032049)Roche Diagnostics Corp.2003-08-22
SYNCHRON SYSTEMS VALPROIC ACID (V-PA) REAGENT (K031870)Beckman Coulter, Inc.2003-07-15
QMS / MULTIGENT VALPROIC ACID REAGENT, PART #396075 (K030405)Seradyn2003-04-28
RANDOX VALPROIC ACID (K011649)Randox Laboratories, Ltd.2002-01-15
EMIT 2000 VALPROIC ACID ASSAY, MODEL OSR4G229UL (K011947)Syva Co.2001-07-02
EMIT 2000 VALPROIC ACID ASSAY, EMIT 2000 VALPROIC ACID CALIBRATORS, MODEL 4G019UL, 4G109UL (K002551)Dade Behring, Inc.2000-10-11
IMMULITE VALPROIC ACID, IMMULITE 2000 VALPROIC ACID, CATALOG # LKVA1, LKVA5 & L2KVA2, L2KVA6 (K000005)Diagnostic Products Corp.2000-03-03
DIMENSION(R) VALPROIC (VALP) ACID METHOD (K982880)Dade Behring, Inc.1998-08-25
ACE VALPROIC ACID REAGENT, AED CALIBRATORS (K973581)Schiapparelli Biosystems, Inc.1997-11-12

Recalls involving this device

RecordFirmDate
Roche VALP2, Online TDM Valproic acid , for use with the Roche/Hitachi Cobas c 501 analyze recall (Z-0920-2007)Roche Diagnostics Corp.2007-06-09

PMA approvals by this applicant

RecordFirmDate
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