Clearance Summary
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS received FDA 510(k) clearance under submission number K870115, sponsored by 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 1987-03-31.
- Submission: K870115
- Applicant / Sponsor: Berthold Analytical Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1987-03-31
Classification & Regulation
This clearance is catalogued under FDA product code JJJ and 21 CFR 862.2320, within the Clinical Chemistry review panel as a Class I device.