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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 K961179
Device Name SENTINEL LIPASE LIQUID MODEL 17.401B
Applicant
Equal Diagnostics, Inc.
115 Summit Dr.
Exton,  PA  19341
Applicant Contact BRENDA Y KAN
Correspondent
Equal Diagnostics, Inc.
115 Summit Dr.
Exton,  PA  19341
Correspondent Contact BRENDA Y KAN
Regulation Number862.1465
Classification Product Code
CHI  
Date Received03/26/1996
Decision Date 07/19/1996
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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