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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K952250
Device Name STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT
Applicant
Dade Intl., Inc.
P.O.Box 520672
Miami,  FL  33152
Applicant Contact JOANN H SMITH
Correspondent
Dade Intl., Inc.
P.O.Box 520672
Miami,  FL  33152
Correspondent Contact JOANN H SMITH
Regulation Number862.1215
Classification Product Code
JHS  
Date Received05/15/1995
Decision Date 07/17/1995
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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