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510(k) K970579

Device
ONE STEP MORPHINE CARD TEST
Applicant
TECO DIAGNOSTICS
510(k) number
K970579
Product code
DNK  
Decision
Substantially Equivalent (SESE)
Decision date
1997-07-03
Date received
1997-02-14
Regulation
862.3640
Classification name
Thin Layer Chromatography, Morphine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANDREW REAMS
Address
4925 E. Hunter Ave. Anaheim CA US 92807 92807

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DNK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K151557EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - MethamphetamineNantong Egens Biotech Co., Ltd.2015-07-16
K150602CR3 Keyless Split Sample Cup Morphine - MethamphetamineGuangzhou Wondfo Biotech Co., Ltd.2015-04-07
K853140MDI QUIK TEST NARCOTICS DRUG SCREENMedical Diagnostics, Ca.1986-03-03

Legacy Summary#

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FDA Review#

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