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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K922754
Device Name TANDEM-E IGE II CALIBRATION VERIFICATION SET
Applicant
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Applicant Contact EUGENE V GOORCHENKO
Correspondent
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Correspondent Contact EUGENE V GOORCHENKO
Regulation Number862.1660
Classification Product Code
JJX  
Date Received06/08/1992
Decision Date 02/17/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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