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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, Opiates
510(k) Number K041747
Device Name IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE)
Applicant
Lifepoint,Inc
1205 S. Dupont St.
Ontario,  CA  91761
Applicant Contact DAVID B GOLDBERG
Correspondent
Lifepoint,Inc
1205 S. Dupont St.
Ontario,  CA  91761
Correspondent Contact DAVID B GOLDBERG
Regulation Number862.3650
Classification Product Code
DJG  
Subsequent Product Code
KHO  
Date Received06/29/2004
Decision Date 11/24/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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