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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Drug Mixture Control Materials
510(k) Number K992395
Device Name URINE DRUG SCREENING CONTROL
Applicant
Seracare Technology
2170 Woodward St.
Austin,  TX  78744
Applicant Contact RUSTY SEWELL
Correspondent
Seracare Technology
2170 Woodward St.
Austin,  TX  78744
Correspondent Contact RUSTY SEWELL
Regulation Number862.3280
Classification Product Code
DIF  
Date Received07/19/1999
Decision Date 08/26/1999
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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