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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Lipase-Esterase, Enzymatic, Photometric, Lipase
510(k) Number K923917
Device Name ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY
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 Number862.1465
Classification Product Code
CHI  
Date Received08/05/1992
Decision Date 02/25/1994
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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