Clearance Summary
REAGENT, FIREFLY #395 received FDA 510(k) clearance under submission number K781807, sponsored by Chrono-Log 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 1978-11-22.
- Submission: K781807
- Applicant / Sponsor: Chrono-Log Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.5700
- Decision date: 1978-11-22
Classification & Regulation
This clearance is catalogued under FDA product code JOZ and 21 CFR 864.5700, within the Hematology review panel as a Class II device.