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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 K921949
Device Name COTUBE PTH IRMA
Applicant
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Applicant Contact SHARON K SMITH
Correspondent
Bio-Rad
4000 Alfred Nobel Dr.
Hercules,  CA  94547
Correspondent Contact SHARON K SMITH
Regulation Number862.1545
Classification Product Code
CEW  
Date Received04/27/1992
Decision Date 09/02/1992
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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