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510(k) K980249

Device
ACCUSIGN TCA, BIOSIGN TCA, STAUS DS TCA
Applicant
PRINCETON BIOMEDITECH CORP.
510(k) number
K980249
Product code
LFG  
Decision
Substantially Equivalent (SESE)
Decision date
1998-03-13
Date received
1998-01-23
Regulation
862.3910
Classification name
Radioimmunoassay, Tricyclic Antidepressant Drugs
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEMO KANG
Address
4242 U.S. Rt. 1 Monmouth Junction NJ US 08852 08852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFG  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151348Healgen Propoxyphene Test (Strip, Cassette, Cup, Dip Card), Healgen Nortriptyline Test (Strip, Cassette, Cup, Dip Card), Healgen EDDP (Methadone Metabolite) Test (Strip, Cassette, Cup, Dip Card)Healgen Scientific,, LLC2015-08-18
K142609CR3 Keyless Split Sample Cup Nortriptyline-BuprenorphineGuangzhou Wondfo Biotech Co., Ltd.2014-12-18
K112395WONDFO PHENCYCLIDINE URINE TEST, TRICYCLIC ANTIDEPRESSANTS URINE TESTGuangzhou Wondfo Biotech Co., Ltd.2011-09-09
K072062UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.2007-09-20
K061457UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTSUcp Biosciences, Inc.2006-08-21
K021526ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICEACON Laboratories, Inc.2002-07-17
K011545VERDICT -II TCA, VERDICT-II MTDMedtox Diagnostics, Inc.2001-06-08
K870823EMIT NORTRIPTYLINE ASSAYSyva Co.1987-03-20
K861155EMIT DESIPRAMINE ASSAYSyva Co.1986-05-02
K853113TD TRICYCLIC ANTIDEPRESSANTSAbbott Laboratories1985-08-12
K844950EMIT AMITRIPTYLINE ASSAYSyva Co.1985-06-28
K844951EMIT IMIPRAMINE ASSAYSyva Co.1985-06-28
K844952EMIT NORTRIPTYLINE ASSAYSyva Co.1985-06-28
K844953EMIT DESIPRAMINE ASSAYSyva Co.1985-06-28
K841532ACA TRICYCLIC ANTIDEPRESSANTS SCREEN TESE.I. Dupont DE Nemours & Co., Inc.1984-05-02

Legacy Summary#

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FDA Review#

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