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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Photometric Method, Iron (Non-Heme)
510(k) Number K863109
Device Name FERROFAST
Applicant
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Applicant Contact DI PIETRO
Correspondent
J. D. Assoc.
163 Montclair Ave.
Montclair,  NJ  07042
Correspondent Contact DI PIETRO
Regulation Number862.1410
Classification Product Code
JIY  
Date Received08/13/1986
Decision Date 11/24/1986
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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