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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Media, Potentiating For In Vitro Diagnostic Use
510(k) Number K781435
Device Name ORTHO LOW IONIC SOLUTION
Applicant
ORTHO DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
ORTHO DIAGNOSTICS, INC.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number864.9600
Classification Product Code
KSG  
Date Received08/16/1978
Decision Date 09/14/1978
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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