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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzymatic Esterase--Oxidase, Cholesterol
510(k) Number K910240
Device Name CHOLESTAT (TM) WHOLE BLOOD CHOLESTEROL TEST
Applicant
Crystal Diagnostics, Inc.
30 Commerce Way
Woburn,  MA  01801
Applicant Contact JOHN SCHULTE
Correspondent
Crystal Diagnostics, Inc.
30 Commerce Way
Woburn,  MA  01801
Correspondent Contact JOHN SCHULTE
Regulation Number862.1175
Classification Product Code
CHH  
Date Received01/22/1991
Decision Date 02/26/1991
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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