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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 K822133
Device Name IGE/THE OPHYLLINE CONTROL SERUM I,II,III
Applicant
KALLESTAD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
KALLESTAD LABORATORIES, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number862.1660
Classification Product Code
JJY  
Date Received07/20/1982
Decision Date 08/03/1982
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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