Clearance Summary
GRAM STAIN received FDA 510(k) clearance under submission number K843050, sponsored by Reagent Laboratory, 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 1984-09-11.
- Submission: K843050
- Applicant / Sponsor: Reagent Laboratory, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1984-09-11
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.