Clearance Summary
1208 BETACORD AND 1208 BETCORD M received FDA 510(k) clearance under submission number K852434, sponsored by Lkb 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 1985-08-02.
- Submission: K852434
- Applicant / Sponsor: Lkb Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1985-08-02
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.