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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name radioimmunoassay, parathyroid hormone
510(k) Number K772249
Device Name COMPLEMENT C3 NEPHELOMETRIC ASSAY
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 Number862.1545
Classification Product Code
CEW  
Date Received12/09/1977
Decision Date 12/22/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
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