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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cresolphthalein complexone, calcium
510(k) Number K871152
Device Name SIGMA'S CALCIUM PROCEDURE NO. 587
Applicant
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Applicant Contact QUINCY E CRIDER,PHD
Correspondent
SIGMA DIAGNOSTICS, INC.
P.O. BOX 14508
ST. LOUIS,  MO  63178
Correspondent Contact QUINCY E CRIDER,PHD
Regulation Number862.1145
Classification Product Code
CIC  
Date Received03/23/1987
Decision Date 06/12/1987
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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