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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 K950211
Device Name ELSA-PTH
Applicant
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Applicant Contact MARY E DONOVAN
Correspondent
Cis-Us, Inc.
10 De Angelo Dr.
Bedford,  MA  01730
Correspondent Contact MARY E DONOVAN
Regulation Number862.1545
Classification Product Code
CEW  
Date Received01/19/1995
Decision Date 04/13/1995
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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