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510(k) K934340

Device
BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTS
Applicant
BIOSITE INCORPORATED
510(k) number
K934340
Product code
LFI  
Decision
Substantially Equivalent (SESE)
Decision date
1994-12-02
Date received
1993-09-08
Regulation
862.3910
Classification name
High Pressure Liquid Chromatography, 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
JOHN F BRUNI
Address
11030 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LFI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K941990BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLCBio-Rad1995-03-20
K941994BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLCBio-Rad1995-03-20
K8022457 TRICYCLIC ANTIDE PRESSANTSTechnicon Instruments Corp.1980-10-10

Legacy Summary#

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FDA Review#

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