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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 K945677
Device Name IL682, CO-OXIMETER
Applicant
Instrumentation Laboratory CO
101 Hartwell Ave.
Lexington,  MA  02421
Applicant Contact WALLIS W CADY
Correspondent
Instrumentation Laboratory CO
101 Hartwell Ave.
Lexington,  MA  02421
Correspondent Contact WALLIS W CADY
Regulation Number864.5620
Classification Product Code
GKR  
Subsequent Product Codes
GGZ   GHS   JKS  
Date Received11/18/1994
Decision Date 10/20/1995
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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