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510(k) K022533

FASTPACK TESTOSTERONE CALIBRATOR by Qualigen, Inc. — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 30, 2002
Date Received
July 31, 2002
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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