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510(k) K913130

STRATUS IINTELLECT IMMUNOASSAY SYSTEM by Baxter Healthcare Corp — Product Code KHO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 27, 1991
Date Received
July 16, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fluorometer, For Clinical Use
Device Class
Class I
Regulation Number
862.2560
Review Panel
CH
Submission Type

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