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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 K833247
Device Name QUANTAPHASE B-12-COBALMIN-FOLATE-
Applicant
Bio-Rad
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Bio-Rad
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number862.1810
Classification Product Code
CDD  
Date Received09/30/1983
Decision Date 10/19/1983
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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