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510(k) K874389

Device
CRACK-IT CHAP SCREEN
Applicant
SAKERS, INC.
510(k) number
K874389
Product code
DMN  
Decision
Substantially Equivalent (SESE)
Decision date
1989-02-07
Date received
1987-10-27
Regulation
862.3250
Classification name
Thin Layer Chromatography, Cocaine
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
AKERS, JR
Address
Plz. 47 800 Delsea Dr., Suite 10 Westville NJ US 08093 08093

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DMN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K972618QUICKSCREEN ONE STEP COCAINE SCREENING TEST (9070)Phamatech1997-08-08

Legacy Summary#

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FDA Review#

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