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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ion-Exchange Chromatography
510(k) Number K840985
Device Name TRISACRYL GF 05 & TRISACRYL GF 2000
Applicant
Lkb Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Lkb Instruments, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2230
Classification Product Code
DJY  
Date Received03/07/1984
Decision Date 04/19/1984
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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