510(k) K234091
K234091 is an FDA 510(k) premarket notification submitted by Genalyte, Inc. for the device "Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0". The FDA issued a decision of Substantially Equivalent on July 22, 2024. The device falls under product code JLW (Radioimmunoassay, Thyroid-Stimulating Hormone), a Class II device regulated under 21 CFR 862.1690. Genalyte, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 22, 2024
- Date Received
- December 26, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radioimmunoassay, Thyroid-Stimulating Hormone
- Device Class
- Class II
- Regulation Number
- 862.1690
- Review Panel
- CH
- Submission Type