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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Colorimetric Method, Cpk Or Isoenzymes
510(k) Number K921763
Device Name TANDEM ICON QSR CKMB IMMUNOENZYMETRIC ASSAY
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 Number862.1215
Classification Product Code
JHY  
Date Received04/14/1992
Decision Date 06/09/1992
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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