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510(k) K953761

Device
AXSYM TRICYCLIC ANTIDEPRESSANTS
Applicant
ABBOTT LABORATORIES
510(k) number
K953761
Product code
LFH  
Decision
Substantially Equivalent (SESE)
Decision date
1995-11-22
Date received
1995-08-11
Regulation
862.3910
Classification name
U.v. Spectrometry, Tricyclic Antidepressant Drugs
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DOUG KENTZ
Address
One Abbott Park Rd. D389, Ap30 Abbott Park IL US 60064 60064

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LFH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K231020Alinity c Tricyclic Antidepressants Reagent KitMicrogenics Corporation2023-11-17
K213875DRI TM Tricyclics Serum Tox AssayMicrogenics Corporation2022-12-21
K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYDiagnostic Reagents, Inc.1998-11-18
K981801ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCAPrinceton BioMeditech Corp.1998-08-25
K961393TRICYCLICS SERUM TOX ASSAYDiagnostic Reagents, Inc.1996-06-12

Legacy Summary#

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FDA Review#

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