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510(k) K003941

ELECSYS HCG STAT CLASET II by Roche Diagnostics Corp. — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 25, 2001
Date Received
December 21, 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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