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U.S. Department of Health and Human Services

510(k) Premarket Notification

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510(k) Number K852787
Device Name TECHNICON H*1 SYSTEM
Applicant
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Applicant Contact LEONARD A DWARICA
Correspondent
Technicon Instruments Corp.
511 Benedict Ave.
New York,  NY  10591
Correspondent Contact LEONARD A DWARICA
Date Received07/01/1985
Decision Date 07/23/1985
Decision Substantially Equivalent (SESE)
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized
No
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