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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K842965
Device Name GASTRIN RADIOIMMUNOASSAY TEST KIT
Applicant
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Applicant Contact MIRIAM STELL
Correspondent
Serono Diagnostics, Inc.
11 Brooks Dr.
Bramtree,  MA  02184
Correspondent Contact MIRIAM STELL
Date Received07/27/1984
Decision Date 10/11/1984
Decision Substantially Equivalent (SESE)
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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