AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)

Enzyme Immunoassay, Cocaine And Cocaine Metabolites

The following data is part of a premarket notification filed by Ameditech, Inc. with the FDA for Ameditech Checkcup Multi Drug Test (flat/round Cup).

Device ID	K113501
510k Number	K113501
Device Name:	AMEDITECH CHECKCUP MULTI DRUG TEST (FLAT/ROUND CUP)
Classification	Enzyme Immunoassay, Cocaine And Cocaine Metabolites
Applicant	AMEDITECH, INC. 10340 CAMINO SANTA FE San Diego, CA 92121
Contact	Brett Casey
Correspondent	Brett Casey AMEDITECH, INC. 10340 CAMINO SANTA FE San Diego, CA 92121
Product Code	DIO
Subsequent Product Code	DIS
Subsequent Product Code	DJC
Subsequent Product Code	DJG
Subsequent Product Code	DJR
Subsequent Product Code	DKZ
Subsequent Product Code	JXM
Subsequent Product Code	JXN
Subsequent Product Code	LCM
Subsequent Product Code	LDJ
Subsequent Product Code	LFG
CFR Regulation Number	862.3250 [🔎]
Decision	Substantially Equivalent (SESE)
Type	Special
3rd Party Reviewed	No
Combination Product	No
Date Received	2011-11-25
Decision Date	2011-12-05
Summary:	summary