Atlas FDA

RANDOX PHENYTOIN

FDA 510(k) clearance K011393 · decided 2001-12-04

Clearance details

K-number
K011393
Device name
RANDOX PHENYTOIN
Applicant
Randox Laboratories, Ltd.
Decision
Substantially Equivalent
Date received
2001-05-07
Decision date
2001-12-04
Days to decision
211 days
Clearance type
Traditional
Product code
DIP
Device class
2
Regulation number
862.3350
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Crumlin, Co. Antrim, IE
Third-party review
No
Expedited review
No

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RecordFirmDate
ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 (K080696)Abbott Laboratories2008-09-11
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ROCHE ONLINE TDM PHENYTOIN (K030428)Roche Diagnostics Corp.2003-04-28
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
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diag recall (Z-0929-2014)Siemens Healthcare Diagnostics, Inc2014-02-04
ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diag recall (Z-0930-2014)Siemens Healthcare Diagnostics, Inc2014-02-04