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510(k) K902575

SOPHEIA 1000 (S1CAL) & SOPHEIA 2000 (S2CAL) by Diagnostic Products Corp. — Product Code JIW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1990
Date Received
June 11, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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