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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 K872063
Device Name TANDEM-E IMMUNOENZYMETRIC ASSAY FOR CKMB II
Applicant
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Applicant Contact S KABAKOFF,PHD
Correspondent
Hybritech, Inc.
11095 Torreyana Rd.
P.O. Box 269006
San Diego,  CA  92126
Correspondent Contact S KABAKOFF,PHD
Regulation Number862.1215
Classification Product Code
JHY  
Date Received05/28/1987
Decision Date 06/19/1987
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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