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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer, For Clinical Use
510(k) Number K781554
Device Name RAD-291
Applicant
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Organon, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2700
Classification Product Code
JQX  
Date Received09/11/1978
Decision Date 10/11/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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