Atlas FDA

TDX METHADONE ASSAY

FDA 510(k) clearance K884968 · decided 1988-12-16

Clearance details

K-number
K884968
Device name
TDX METHADONE ASSAY
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1988-11-30
Decision date
1988-12-16
Days to decision
16 days
Clearance type
Traditional
Product code
DJR
Device class
2
Regulation number
862.3620
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
TDx/TDxFLx Methadone, list 9676-60; Abbott Laboratories, Diagnostics Division, Abbott Park recall (Z-0510-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04
ADx Methadone, list 9676-55; Abbott Laboratories, Diagnostics Division, Abbott Park, IL 60 recall (Z-0511-04)Abbott Laboratories HPD/ADD/GPRD2004-02-04

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