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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K992939
Device Name QUALITROL IMMUNOASSAY PLUS CONTROL, LEVELS 1,2 AND 3
Applicant
Seracare Technology
2170 Woodward St.
Austin,  TX  78744 -1832
Applicant Contact RUSTY SEWELL
Correspondent
Seracare Technology
2170 Woodward St.
Austin,  TX  78744 -1832
Correspondent Contact RUSTY SEWELL
Regulation Number862.1660
Classification Product Code
JJY  
Date Received08/31/1999
Decision Date 12/09/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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