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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioimmunoassay, Gastrin
510(k) Number K842079
Device Name GASTRIN 34 HORMONE BY RADIOUMMUNOASSAY
Applicant
Immuno Nuclear Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Immuno Nuclear Corp.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1325
Classification Product Code
CGC  
Date Received05/23/1984
Decision Date 06/26/1984
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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