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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Counter, Differential Cell
510(k) Number K923773
Device Name CELLEXIS HEMATOLOGY ANALYZER
Applicant
Technalysis, Inc.
1805 Rutherford Ln.
Austin,  TX  78754
Applicant Contact STEPHEN C BIBY
Correspondent
Technalysis, Inc.
1805 Rutherford Ln.
Austin,  TX  78754
Correspondent Contact STEPHEN C BIBY
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received07/24/1992
Decision Date 02/05/1993
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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