Clearance Summary
MYCOPLASMA DETECTION KIT received FDA 510(k) clearance under submission number K771867, sponsored by Bioassay Systems Research Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1977-11-17.
- Submission: K771867
- Applicant / Sponsor: Bioassay Systems Research Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2360
- Decision date: 1977-11-17
Classification & Regulation
This clearance is catalogued under FDA product code KPB and 21 CFR 864.2360, within the Hematology review panel as a Class I device.