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510(k) K822241

FOLATE/B12 DUO-BEAD RADIOASSAY by Abbott Laboratories — Product Code CEN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1982
Date Received
July 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dye-Indicator, Ph (Urinary, Non-Quantitative)
Device Class
Class I
Regulation Number
862.1550
Review Panel
CH
Submission Type

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