Clearance Summary
STERITEC STEAM BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR, MODEL BI 103 received FDA 510(k) clearance under submission number K001444, sponsored by Steritec Products, Inc.. The device was reviewed via the Special premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2000-05-15.
- Submission: K001444
- Applicant / Sponsor: Steritec Products, Inc.
- Clearance pathway: Special
- Review panel: General Hospital
- Device class: Class II
- Regulation citation: 21 CFR 880.2800
- Decision date: 2000-05-15
Classification & Regulation
This clearance is catalogued under FDA product code JOJ and 21 CFR 880.2800, within the General Hospital review panel as a Class II device.