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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 K861097
Device Name TRYPSIN RIA KIT
Applicant
Microanalytic Research, Inc.
23461 Ridge Rte. Unit H
Laguna Hills,  CA  92653
Applicant Contact JEFFREY C TRAVIS
Correspondent
Microanalytic Research, Inc.
23461 Ridge Rte. Unit H
Laguna Hills,  CA  92653
Correspondent Contact JEFFREY C TRAVIS
Regulation Number862.1725
Classification Product Code
JNO  
Date Received03/24/1986
Decision Date 05/29/1986
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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