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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name apparatus, electrophoresis, for clinical use
510(k) Number K822285
Device Name CELLULOSE ACETATE MEMBRANE STRIPS
Applicant
SARTORIUS FILTERS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
SARTORIUS FILTERS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.2485
Classification Product Code
JJN  
Date Received07/30/1982
Decision Date 09/21/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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