Clearance Summary
BERTHOLD LB 954 received FDA 510(k) clearance under submission number K922329, sponsored by Eg&G Berthold Analytical Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1992-11-16.
- Submission: K922329
- Applicant / Sponsor: Eg&G Berthold Analytical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2300
- Decision date: 1992-11-16
Classification & Regulation
This clearance is catalogued under FDA product code JJQ and 21 CFR 862.2300, within the Clinical Chemistry review panel as a Class I device.