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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Cell, Automated (Particle Counter)
510(k) Number K930685
Device Name TECHNICON H* 3TM RTC SYSTEM (IN-VITRO DIAG.SYST.)
Applicant
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Applicant Contact GABRIEL J MURACA
Correspondent
Heraeus Kulzer, Inc.
511 Benedict Ave.
Tarrytown,  NY  10591
Correspondent Contact GABRIEL J MURACA
Regulation Number864.5200
Classification Product Code
GKL  
Date Received02/10/1993
Decision Date 06/22/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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