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510(k) K003969

ELECSYS CA 125 II CALSET by Roche Diagnostics Corp. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 2001
Date Received
December 22, 2000
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Primary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

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