Clearance Summary
BLASTOMYCES YEAST ANTIGEN received FDA 510(k) clearance under submission number K760828, sponsored by I M, 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 1976-11-01.
- Submission: K760828
- Applicant / Sponsor: I M, Inc.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.2320
- Decision date: 1976-11-01
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.