Clearance Summary
WESCOR GRAM STAIN PACK FOR MODEL 7300 AEROSPRAY received FDA 510(k) clearance under submission number K881512, sponsored by Wescor, 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 1988-04-18.
- Submission: K881512
- Applicant / Sponsor: Wescor, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1988-04-18
Classification & Regulation
This clearance is catalogued under FDA product code JTS and 21 CFR 864.1850, within the Hematology review panel as a Class I device.