Clearance Summary
BIOSIGN STREP A - DIRECT STREP A ANTIGEN TEST received FDA 510(k) clearance under submission number K971349, sponsored by Princeton BioMeditech Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Microbiology review panel. The statutory decision date of record is 1997-07-07.
- Submission: K971349
- Applicant / Sponsor: Princeton BioMeditech Corp.
- Clearance pathway: Traditional
- Review panel: Microbiology
- Device class: Class I
- Regulation citation: 21 CFR 866.3740
- Decision date: 1997-07-07
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.