Atlas FDA

TD TRICYCLIC ANTIDEPRESSANTS

FDA 510(k) clearance K853113 · decided 1985-08-12

Clearance details

K-number
K853113
Device name
TD TRICYCLIC ANTIDEPRESSANTS
Applicant
Abbott Laboratories
Decision
Substantially Equivalent
Date received
1985-07-24
Decision date
1985-08-12
Days to decision
19 days
Clearance type
Traditional
Product code
LFG
Device class
2
Regulation number
862.3910
Medical specialty
Clinical Toxicology
Advisory committee
Clinical Toxicology
Location
Abbott Park, IL, US
Third-party review
No
Expedited review
No

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ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA (K980249)Princeton BioMeditech Corp.1998-03-13
EMIT NORTRIPTYLINE ASSAY (K870823)Syva Co.1987-03-20
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EMIT IMIPRAMINE ASSAY (K844951)Syva Co.1985-06-28
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Recalls involving this device

RecordFirmDate
TDx/TDxFLx Tricyclic Antidepressants Reagent. Distributed under the following label: TDx/T recall (Z-0325-04)Abbott Health Products, Inc.2004-01-10
TDx/TDxFLx TDx/TDxFLX Tricyclic Antidepressant Reagent Distributed under the following lab recall (Z-0691-03)Abbott Health Products, Inc.2003-03-29

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