FDA 510(k) K231465, Q-Pad Test System, Hyman, Phelps & McNamara P.C.

FDA 510(k) K231465, Q-Pad Test System, Hyman, Phelps & McNamara P.C.

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510(K) Number: K231465
Device Name: Q-Pad Test System
Manufacturer: Hyman, Phelps & McNamara P.C.
Device Classification Name: Assay, Glycosylated Hemoglobin
Regulation Number: 864.7470
Classification Product Code: LCP
Date Received: 05/19/2023
Decision Date: 12/06/2023
Regulation Medical Specialty: Clinical Chemistry
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