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510(k) K853140

Device
MDI QUIK TEST NARCOTICS DRUG SCREEN
Applicant
MEDICAL DIAGNOSTICS, CA.
510(k) number
K853140
Product code
DNK  
Decision
Substantially Equivalent (SESE)
Decision date
1986-03-03
Date received
1985-07-29
Regulation
862.3640
Classification name
Thin Layer Chromatography, Morphine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
FRANK 0 HOLCOMBE
Address
9062 Rte. 108 Columbia MD US 21045 21045

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
K970579ONE STEP MORPHINE CARD TESTTeco Diagnostics1997-07-03

Legacy Summary#

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FDA Review#

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