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.
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
Couldn't load pickup availability
PLEASE NOTE: Most 510(k)s obtained through FOIA are heavily redacted, often omitting sections related to testing, software, manufacturing, and other technical data. Please be sure to review the total pages, redacted pages, and content pages listed in the description to get a sense of how much of the document is redacted. As the FDA FOIA office explains: “We HEAVILY REDACT the majority of the following portions of 510(k) filings: testing data, technical data, lab reports, manufacturing information, vendor information, substantive discussions regarding deficiencies or additional information requests, internal FDA communications, software and risk analysis, specifications, SOPs, unpublished studies, draft manuals, etc.” If you’d like more details about a specific document before purchasing, please contact us at info@foiadocs.com.
View full details