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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 K883011
Device Name MRI NEO-TRYP TRYPSIN RIA
Applicant
Microbiological Research Corp.
23461 Ridge Rte. Unit H
Laguna Hills,  CA  92653
Applicant Contact C TRAVIS,PHD
Correspondent
Microbiological Research Corp.
23461 Ridge Rte. Unit H
Laguna Hills,  CA  92653
Correspondent Contact C TRAVIS,PHD
Regulation Number862.1725
Classification Product Code
JNO  
Date Received07/19/1988
Decision Date 04/26/1989
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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