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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 K854245
Device Name SIGMA ANGIOTENSIN CONVERTING ENZYME 305-UV
Applicant
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Applicant Contact QUINCY E CRIDER
Correspondent
Sigma Diagnostics, Inc.
P.O. Box 14508
St. Louis,  MO  63178
Correspondent Contact QUINCY E CRIDER
Regulation Number862.1090
Classification Product Code
KQN  
Date Received10/21/1985
Decision Date 01/22/1986
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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