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510(k) K011658

CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) LIPIDS by Rochdiag — Product Code JIX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 31, 2001
Date Received
May 29, 2001
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Multi-Analyte Mixture
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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