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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K961195
Device Name CHEM-CHEX STAT
Applicant
Streck Laboratories, Inc.
14306 Industrial Rd.
Omaha,  NE  68144
Applicant Contact Theodore Heise
Correspondent
Streck Laboratories, Inc.
14306 Industrial Rd.
Omaha,  NE  68144
Correspondent Contact Theodore Heise
Regulation Number862.1660
Classification Product Code
JJY  
Date Received03/27/1996
Decision Date 05/15/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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