Clearance Summary
CASE WRIGHT-GIEMSA STAIN PAK received FDA 510(k) clearance under submission number K831131, sponsored by Case Instruments. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1983-06-08.
- Submission: K831131
- Applicant / Sponsor: Case Instruments
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1983-06-08
Classification & Regulation
This clearance is catalogued under FDA product code HYF and 21 CFR 864.1850, within the Hematology review panel as a Class I device.