Atlas FDA

ROCHE ONLINE TDM PHENYTOIN

FDA 510(k) clearance K030428 · decided 2003-04-28

Clearance details

K-number
K030428
Device name
ROCHE ONLINE TDM PHENYTOIN
Applicant
Roche Diagnostics Corp.
Decision
Substantially Equivalent
Date received
2003-02-10
Decision date
2003-04-28
Days to decision
77 days
Clearance type
Traditional
Product code
DIP
Device class
2
Regulation number
862.3350
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Indianapolis, IN, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696)Abbott Laboratories2008-09-11
PHENOBARBITAL, PHENYTOIN, TDM CALIBRATION SET B AND ABTROL/NORTROL CONTROLS (K063145)Thermo Electron OY2007-10-17
RANDOX PHENYTOIN (K011393)Randox Laboratories, Ltd.2001-12-04
EMIT 2000 PHENYTOIN ASSAY, MODEL 0SR4A229 (K011347)Syva Co.2001-05-17
IMMULITE PHENYTOIN, IMMULITE 2000 PHENYTOIN, CATALOG # LKPN1, LKPN5 & L2KPN2, L2KPN6 (K000006)Diagnostic Products Corp.2000-02-28
ABBOT AEROSET PHENYTOIN ASSAY & ABBOT AEROSET PHENYTOIN CALIBRATORS (K993026)Syva Co.2000-01-27
ACE PHENYTOIN REAGENT, AED CALIBRATORS (K973414)Schiapparelli Biosystems, Inc.1997-11-04
CEDIA PHENYTOIN II ASSAY (K963840)Boehringer Mannheim Corp.1996-11-20
IL TEST PHENYTION CALIBRATORS (K943980)Instrumentation Laboratory CO1995-05-01
PHENYTION EIA TEST (K945725)Diagnostic Reagents, Inc.1995-02-03
ACE(TM) CEDIA(R) PHENYTOIN ASSAY (K944085)Schiapparelli Biosystems, Inc.1994-12-28
KODAK EKTACHEM CLINICAL CHEMISTRY SLIDE PHENYTOIN (K941142)Eastman Kodak Company1994-06-13

Recalls involving this device

RecordFirmDate
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 2 x 17 ml phenytoin conjugat recall (Z-1062-04)Roche Diagnostics Corp.2004-07-20
Roche/Hitachi brand ONLINE TDM Phenytoin; Contents of kit: 1- 1 x 37 ml phenytoin conjugat recall (Z-1063-04)Roche Diagnostics Corp.2004-07-20

PMA approvals by this applicant

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Elecsys Anti-HBs (P010054/S048)Roche Diagnostics Corp.2025-05-22
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