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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Single (Specified) Analyte Controls (Assayed And Unassayed)
510(k) Number K001443
Device Name SUGAR CHEX ONE
Applicant
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Applicant Contact PAUL KITTELSON
Correspondent
Streck Laboratories, Inc.
14124 Industrial Rd.
Omaha,  NE  68145
Correspondent Contact PAUL KITTELSON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received05/08/2000
Decision Date 06/29/2000
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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