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510(k) K013548

STANDARD IMAGING IVB 1000 WELL CHAMBER by Standard Imaging, Inc. — Product Code KPT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 9, 2001
Date Received
October 24, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Dose, Radionuclide
Device Class
Class II
Regulation Number
892.1360
Review Panel
RA
Submission Type

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