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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 K881361
Device Name SOLID PHASE EXTRACTION TUBES
Applicant
Supelco, Inc.
Supelco Park
Bellefonte,  PA  16823
Applicant Contact LLOYD A WITTING
Correspondent
Supelco, Inc.
Supelco Park
Bellefonte,  PA  16823
Correspondent Contact LLOYD A WITTING
Regulation Number862.2230
Classification Product Code
DJY  
Date Received02/16/1988
Decision Date 08/08/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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