Clearance Summary
ZYMMUNE AUTOREADER-F FLUORESCENCE MICROPLATE READER received FDA 510(k) clearance under submission number K962499, sponsored by Bartels, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1996-09-05.
- Submission: K962499
- Applicant / Sponsor: Bartels, Inc.
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.4520
- Decision date: 1996-09-05
Classification & Regulation
This clearance is catalogued under FDA product code JZT and 21 CFR 866.4520, within the Immunology review panel as a Class I device.