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510(k) K801662

J.T. BAKER ALPHA-2-MACROGLOBULIN NEPH. by J.T. Baker Chemical Co. — Product Code DEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 1980
Date Received
July 21, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Lambda, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
PA
Submission Type

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