K234091
- 510(k) number
- K234091
- Device name
- Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
- Applicant
- Genalyte, Inc. CA · US
- Product code
- JLW — Radioimmunoassay, Thyroid-Stimulating Hormone
- Decision date
- 2024-07-22
- Date received
- 2023-12-26
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Clinical Chemistry
This submission filed a 510(k) Statement rather than a Summary; no public summary is available from FDA.
Official FDA record: K234091
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.