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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Immunoassay, Amphetamine
510(k) Number K052115
Device Name FIRST CHECK MULTI DRUG CUP 12 FOR MARIJUANA (THC), COCAINE (COC), AMPHETAMINE (AMP), METHAMPHETAMINE (MET), ECSTASY
Applicant
FIRST CHECK DIAGNOSTICS LLC
13 SPECTRUM POINTE DR.
LAKE FOREST,  CA  92630
Applicant Contact KEVIN J GADAWSKI
Correspondent
FIRST CHECK DIAGNOSTICS LLC
13 SPECTRUM POINTE DR.
LAKE FOREST,  CA  92630
Correspondent Contact KEVIN J GADAWSKI
Regulation Number862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
JXM   LCM   LDJ   LFG  
Date Received08/04/2005
Decision Date 12/29/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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