Atlas FDA

AXSYM PHENYTOIN II

FDA 510(k) clearance K953840 · decided 1995-09-25

Clearance details

K-number
K953840
Device name
AXSYM PHENYTOIN II
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1995-08-16
Decision date
1995-09-25
Days to decision
40 days
Clearance type
Traditional
Product code
LGR
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
ACS PHENYTOIN ASSAY (K955873)Ciba Corning Diagnostics Corp.1996-03-11
INNOFLUOR PHENYTOIN ASSAY SYSTEM (K955562)Oxis Intl., Inc.1996-01-24
TDX(R)/TDXFLX(R) PHENYTOIN II (K946328)Abbott Laboratories1995-03-28
PHENYTOIN FPIA REAGENT SET AND CALIBRATORS (K943313)Sigma Diagnostics, Inc.1994-10-27
AXSYM PHENYTOIN ASSAY (K935375)Abbott Laboratories1994-06-21
COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRATORS (K936131)Roche Diagnostic Systems, Inc.1994-03-11
OPUS PHENYTOIN TEST SYSTEM (K896868)Pb Diagnostic Systems, Inc.1990-01-02
INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SET (K895827)Innotron of Oregon, Inc.1989-10-31
INNOTRON INNOFLUOR PHEYTOIN REAGENT SET (K872563)Innotron of Oregon, Inc.1987-08-21
IMMPULSE PHENYTOIN ASSAY REAGENT (K862554)Sclavo, Inc.1986-07-16
COBAS FP REAGENTS FOR PHENYTOIN & CALIBR (K843824)Roche Diagnostic Systems, Inc.1985-02-01
PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTE (K844171)Bd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10

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