Clearance Summary
HEMATOLOGY ANALYZER received FDA 510(k) clearance under submission number K842310, sponsored by Hml Inc/Biotechnology Transfer. 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 1984-09-06.
- Submission: K842310
- Applicant / Sponsor: Hml Inc/Biotechnology Transfer
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1060
- Decision date: 1984-09-06
Classification & Regulation
This clearance is catalogued under FDA product code JKL and 21 CFR 862.1060, within the Clinical Chemistry review panel as a Class I device.