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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Assay, Carboxyhemoglobin
510(k) Number K770209
Device Name ECOLYZER CARBOXIMETER
Applicant
Iadec, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Iadec, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7425
Classification Product Code
GHS  
Date Received01/31/1977
Decision Date 03/07/1977
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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