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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 K003209
Device Name URINE OPIATES (OPI) SCREEN FLEX REAGENT CARTRIDGE, CATALOG NO. DF93A
Applicant
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Applicant Contact CATHY P CRAFT
Correspondent
Dade Behring, Inc.
P.O. Box 6101
Glasgow Bldg. 500
Newark,  DE  19714
Correspondent Contact CATHY P CRAFT
Regulation Number862.3650
Classification Product Code
DJG  
Date Received10/13/2000
Decision Date 12/05/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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