Clearance Summary
MODELS IDA-2 PLUS AND IPT-1 received FDA 510(k) clearance under submission number K961862, sponsored by Bio-Tek Instruments, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 1997-02-26.
- Submission: K961862
- Applicant / Sponsor: Bio-Tek Instruments, Inc.
- Clearance pathway: Traditional
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.5725
- Decision date: 1997-02-26
Classification & Regulation
This clearance is catalogued under FDA product code FRN and 21 CFR 880.5725, within the General Hospital review panel as a Class II device.