Clearance Summary
REPTILASE -PC received FDA 510(k) clearance under submission number K843207, sponsored by Bio/Data 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 1984-10-23.
- Submission: K843207
- Applicant / Sponsor: Bio/Data Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.8100
- Decision date: 1984-10-23
Classification & Regulation
This clearance is catalogued under FDA product code JCO and 21 CFR 864.8100, within the Hematology review panel as a Class II device.