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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Plasma Viscometer For Clinical Use
510(k) Number K883503
Device Name COULTER VISCOMETER II
Applicant
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Applicant Contact RICHARDSON-JONES
Correspondent
Coulter Electronics, Inc.
745 W. 83rd St.
Hialeah,  FL  33014
Correspondent Contact RICHARDSON-JONES
Regulation Number862.2920
Classification Product Code
JJL  
Date Received08/17/1988
Decision Date 09/19/1988
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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