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510(k) K022901

VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS by Ortho-Clinical Diagnostics — Product Code JIS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 2002
Date Received
September 3, 2002
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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