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510(k) K033009

ROCHE DIAGNOSTICS COBAS INTEGRA ALBUMIN GEN. 2 by Roche Diagnostics Corp. — Product Code CIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 16, 2003
Date Received
September 26, 2003
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bromcresol Green Dye-Binding, Albumin
Device Class
Class II
Regulation Number
862.1035
Review Panel
CH
Submission Type

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