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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 K913496
Device Name CHOLINESTERASE LINEARITY CONTROL
Applicant
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Applicant Contact GARY J PROKSCH
Correspondent
Creative Laboratory Products, Inc.
6258 La Pas Trl.
Indianapolis,  IN  46268
Correspondent Contact GARY J PROKSCH
Regulation Number862.1660
Classification Product Code
JJX  
Date Received08/06/1991
Decision Date 09/11/1991
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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