Clearance Summary
WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S received FDA 510(k) clearance under submission number K852138, sponsored by Canyon Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1985-06-13.
- Submission: K852138
- Applicant / Sponsor: Canyon Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1985-06-13
Classification & Regulation
This clearance is catalogued under FDA product code IAF and 21 CFR 864.1850, within the Hematology review panel as a Class I device.