Clearance Summary
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES received FDA 510(k) clearance under submission number K871483, sponsored by Isratech Marketing Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1987-04-29.
- Submission: K871483
- Applicant / Sponsor: Isratech Marketing Corp.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class I
- Regulation citation: 21 CFR 864.2240
- Decision date: 1987-04-29
Classification & Regulation
This clearance is catalogued under FDA product code KIZ and 21 CFR 864.2240, within the Hematology review panel as a Class I device.