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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Hemoglobin, Automated
510(k) Number K870210
Device Name CLEARVIEW CW-10
Applicant
Clearview Instruments, Inc.
481 Gleasondale Rd.
Stow,  MA  01775
Applicant Contact MARIO LESLIE
Correspondent
Clearview Instruments, Inc.
481 Gleasondale Rd.
Stow,  MA  01775
Correspondent Contact MARIO LESLIE
Regulation Number864.5620
Classification Product Code
GKR  
Date Received01/20/1987
Decision Date 04/28/1987
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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