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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name N-Benzoyl-L-Arginine Ethyl Ester (U.V.), Trypsin
510(k) Number K932406
Device Name NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KIT
Applicant
Nuclear Diagnostics, Inc.
3322 Commercial Ave.
Northbrook,  IL  60062
Applicant Contact JOEL GLOVSKY
Correspondent
Nuclear Diagnostics, Inc.
3322 Commercial Ave.
Northbrook,  IL  60062
Correspondent Contact JOEL GLOVSKY
Regulation Number862.1725
Classification Product Code
JNO  
Date Received05/13/1993
Decision Date 12/02/1993
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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