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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 K912027
Device Name CALCIUM (ARSENAZO III) REAGENT, UNIVERSAL
Applicant
Enzyme Technology, Inc.
415 Howe Ave.
Shelton,  CT  06484
Applicant Contact PETER R KLAMKA
Correspondent
Enzyme Technology, Inc.
415 Howe Ave.
Shelton,  CT  06484
Correspondent Contact PETER R KLAMKA
Regulation Number862.1145
Classification Product Code
CIC  
Date Received05/08/1991
Decision Date 01/30/1992
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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