Clearance Summary
GRAM STAIN SET W/STABILIZED IODINE received FDA 510(k) clearance under submission number K843429, sponsored by Accra Laboratories, 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 1984-09-14.
- Submission: K843429
- Applicant / Sponsor: Accra Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1984-09-14
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.