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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 K851043
Device Name SUGAR-CHEX II
Applicant
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Applicant Contact HALVOR SORNSON
Correspondent
Streck Laboratories, Inc.
P.O. Box 37625
Omaha,  NE  68137
Correspondent Contact HALVOR SORNSON
Regulation Number862.1660
Classification Product Code
JJX  
Date Received03/14/1985
Decision Date 04/29/1985
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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