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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 K843685
Device Name C-TERMINAL/MID-MOLECULE PARATHYROID -
Applicant
NICHOLS INSTITUTE DIAGNOSTICS
P.O. BOX 92797
LOS ANGELES,  CA  90009
Applicant Contact ELAINE WALTON
Correspondent
NICHOLS INSTITUTE DIAGNOSTICS
P.O. BOX 92797
LOS ANGELES,  CA  90009
Correspondent Contact ELAINE WALTON
Regulation Number862.1545
Classification Product Code
CEW  
Date Received09/18/1984
Decision Date 10/11/1984
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
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