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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Automated Cell-Locating
510(k) Number K772140
Device Name SCANNING SYS., AUTO. COMP., ACS1000
Applicant
HONEYWELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
HONEYWELL, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.5260
Classification Product Code
JOY  
Date Received11/14/1977
Decision Date 12/05/1977
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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