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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K823462
Device Name SINGLE VIAL AMYLASE PNP TEST
Applicant
Boehringer Mannheim Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Boehringer Mannheim Corp.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received11/19/1982
Decision Date 12/28/1982
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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