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510(k) K002760

ELECSYS DHEA-S CALSET by Roche Diagnostics Corp. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 2000
Date Received
September 5, 2000
Clearance Type
Traditional
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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