Atlas FDA

VISION PHENYTOIN

FDA 510(k) clearance K896074 · decided 1989-11-17

Clearance details

K-number
K896074
Device name
VISION PHENYTOIN
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1989-10-19
Decision date
1989-11-17
Days to decision
29 days
Clearance type
Traditional
Product code
DIP
Device class
2
Regulation number
862.3350
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

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
ROCHE ONLINE TDM PHENYTOIN (K030428)Roche Diagnostics Corp.2003-04-28
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
ARCHITECT CORE / Alinity i Anti-HBc (P080023/S046)Abbott Laboratories2025-04-03
ARCHITECT AFP / Alinity i AFP (P120008/S030)Abbott Laboratories2025-04-03
ARCHITECT CORE-M / Alinity i Anti-HBc IgM (P060035/S043)Abbott Laboratories2025-04-03
ARCHITECT Total PSA / Alinity i Total PSA (P910007/S066)Abbott Laboratories2025-04-03
ARCHITECT Free PSA / Alinity i Free PSA (P980007/S055)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Qualitative/Qualitative Confirmatory / Alinity i HBsAg Qualitative II/Qualitative II Confirmatory (P110029/S052)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative / ARCHITECT HBsAg Next Confirmatory/ Alinity i HBsAg Next Qualitative/Alinity i HBsAg N (P210003/S013)Abbott Laboratories2025-04-03
ARCHITECT HBsAg Next Qualitative/Next Confirmatory, Alinity i HBsAg Next Qualitative/Next Confirmatory (P210003/S012)Abbott Laboratories2024-09-30