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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catalytic Methods, Amylase
510(k) Number K900230
Device Name COULTER AMYLASE REAGENT
Applicant
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact A RICHARDSON-JONES
Correspondent
Coulter Corp.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact A RICHARDSON-JONES
Regulation Number862.1070
Classification Product Code
JFJ  
Date Received01/17/1990
Decision Date 04/03/1990
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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