Home / 510(k) Clearances / K000611

510(k) K000611

STELLER CD61 ASSAY FOR USE ON THE IMAGN 2000 MICROVOLUME FLUORIMETER by Bd Biosciences — Product Code GKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 18, 2000
Date Received
February 23, 2000
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Counter, Differential Cell
Device Class
Class II
Regulation Number
864.5220
Review Panel
HE
Submission Type

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