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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Radioassay, Vitamin B12
510(k) Number K853224
Device Name PHASE II B-12/FOLATE KIT
Applicant
Medical & Scientific Designs, Inc.
273 Weymouth St.
Rockland,  MA  02370
Applicant Contact KENNETH L HOFFMAN
Correspondent
Medical & Scientific Designs, Inc.
273 Weymouth St.
Rockland,  MA  02370
Correspondent Contact KENNETH L HOFFMAN
Regulation Number862.1810
Classification Product Code
CDD  
Date Received08/01/1985
Decision Date 10/03/1985
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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