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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name mixture, hematology quality control
510(k) Number K781572
Device Name NORMAL HEMATOLOGY CONTROL UNASSAYED
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 Number864.8625
Classification Product Code
JPK  
Date Received09/14/1978
Decision Date 10/17/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
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