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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Saccharogenic, Amylase
510(k) Number K951494
Device Name AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)
Applicant
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Applicant Contact CAROL FAULKNER
Correspondent
Emd Chemicals, Inc.
480 S. Democrat Rd.
Gibbstown,  NJ  08027
Correspondent Contact CAROL FAULKNER
Regulation Number862.1070
Classification Product Code
CIJ  
Date Received03/31/1995
Decision Date 12/11/1995
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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