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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nitroprusside, Ketones (Urinary, Non-Quant.)
510(k) Number K830975
Device Name PLAN A LIFE
Applicant
New Directions Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
New Directions Co.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.1435
Classification Product Code
JIN  
Date Received03/25/1983
Decision Date 05/04/1983
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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