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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 K991883
Device Name REDI-TEST OPIATES
Applicant
Advantage Diagnostics Corp.
3573 Westwind Blvd.
Santa Rosa,  CA  95403
Applicant Contact JANIS FREESTONE
Correspondent
Advantage Diagnostics Corp.
3573 Westwind Blvd.
Santa Rosa,  CA  95403
Correspondent Contact JANIS FREESTONE
Regulation Number862.3650
Classification Product Code
DJG  
Date Received06/02/1999
Decision Date 09/15/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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