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510(k) K003096

FASTPACK CALIBRATORS by Qualigen, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 30, 2000
Date Received
October 3, 2000
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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  • K163544 — Lumipulse G Prolactin (January 12, 2017)
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