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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Angiotensin Converting Enzyme
510(k) Number K942497
Device Name ANGIOTENSIN CONVERTING ENZYME REA
Applicant
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Applicant Contact RICHARD CONLEY
Correspondent
American Laboratory Products Co., Ltd.
P.O. Box 451
Windham,  NH  03087
Correspondent Contact RICHARD CONLEY
Regulation Number862.1090
Classification Product Code
KQN  
Date Received05/17/1994
Decision Date 11/15/1994
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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