Clearance Summary
IMPROVED GRAM STAIN REAGENTS received FDA 510(k) clearance under submission number K791711, sponsored by Carr-Scarborough Microbiologicals, 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 1979-10-17.
- Submission: K791711
- Applicant / Sponsor: Carr-Scarborough Microbiologicals, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.1850
- Decision date: 1979-10-17
Classification & Regulation
This clearance is catalogued under FDA product code HYI and 21 CFR 864.1850, within the Hematology review panel as a Class I device.