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510(k) K060774

FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208 by Beckman Coulter, Inc. — Product Code CGN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 2006
Date Received
March 22, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Acid, Folic, Radioimmunoassay
Device Class
Class II
Regulation Number
862.1295
Review Panel
CH
Submission Type

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