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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 K921252
Device Name TANDEM-E FERRITIN CALIBRATION VERIFICATION CONROL
Applicant
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Applicant Contact JOANNE MARTINIS
Correspondent
Hybritech, Inc.
P.O. Box 269006
San Diego,  CA  92196
Correspondent Contact JOANNE MARTINIS
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/16/1992
Decision Date 07/17/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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