Clearance Summary
RESPIRASTICK ENZYME IMMUNOASSAY TEST received FDA 510(k) clearance under submission number K862475, sponsored by Orion Diagnostica, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1986-09-16.
- Submission: K862475
- Applicant / Sponsor: Orion Diagnostica, Inc.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 1986-09-16
Classification & Regulation
This clearance is catalogued under FDA product code GTY and 21 CFR 866.3740, within the Microbiology review panel as a Class I device.