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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Solution, Isotonic
510(k) Number K761183
Device Name LYSING AGENT AF
Applicant
Central Labs. Assoc. MD Pathologists
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Central Labs. Assoc. MD Pathologists
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.4010
Classification Product Code
JCE  
Date Received12/02/1976
Decision Date 01/17/1977
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Pathology
510k Review Panel Pathology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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