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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Calcitonin
510(k) Number K951708
Device Name ELSA-HCT
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 Number862.1140
Classification Product Code
JKR  
Subsequent Product Codes
JIT   JJX  
Date Received04/13/1995
Decision Date 09/05/1995
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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