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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electrophoretic Separation, Lipoproteins
510(k) Number K971157
Device Name MACRALP(A) ENZYME IMMUNOASSAY KIT
Applicant
Strategic Diagnostics, Inc.
128 Sandy Dr.
Newark,  DE  19713
Applicant Contact JOSEPH X DAUTLICK
Correspondent
Strategic Diagnostics, Inc.
128 Sandy Dr.
Newark,  DE  19713
Correspondent Contact JOSEPH X DAUTLICK
Regulation Number862.1475
Classification Product Code
JHO  
Subsequent Product Code
DFC  
Date Received03/28/1997
Decision Date 04/15/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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