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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 K861797
Device Name ALLEGRO INTACT PARATHYROID HORMONE IMMUNOASSAY
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 Received05/09/1986
Decision Date 07/22/1986
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
Recalls CDRH Recalls
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