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510(k) K941990

Device
BENOZODIAZEPINES AND TRICYLIC ANTIDEPRESSANTS BY HPLC
Applicant
BIO-RAD
510(k) number
K941990
Product code
LFI  
Decision
Substantially Equivalent (SESE)
Decision date
1995-03-20
Date received
1994-04-25
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 NELSON
Address
4000 Alfred Nobel Dr. Hercules CA US 94547 94547

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
K941994BENZODIAZEPINES AND TRICYCLIC ANTIDEPRESSANTS BY HPLCBio-Rad1995-03-20
K934340BIOSITE DIAGNOSTICS - TRIAGE PANEL FOR DRUGS OF ABUSE PLUS TRICYCLIC ANTIDEPRESSANTSBiosite Incorporated1994-12-02
K8022457 TRICYCLIC ANTIDE PRESSANTSTechnicon Instruments Corp.1980-10-10

Legacy Summary#

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FDA Review#

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