Clearance Summary
SR30/SR50/SR60 AUTOMATED SEDIMENTATION RATE received FDA 510(k) clearance under submission number K890503, sponsored by Gespac, 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 1989-02-10.
- Submission: K890503
- Applicant / Sponsor: Gespac, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.5800
- Decision date: 1989-02-10
Classification & Regulation
This clearance is catalogued under FDA product code GKB and 21 CFR 864.5800, within the Hematology review panel as a Class I device.