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510(k) K043378

DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT by Drew Scientific , Ltd. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 2004
Date Received
December 8, 2004
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

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

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