Clearance Summary
INCSTAR HSZ I/II IGG ELISA ASSAY received FDA 510(k) clearance under submission number K955363, sponsored by Incstar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Pathology review panel. The statutory decision date of record is 1996-07-24.
- Submission: K955363
- Applicant / Sponsor: Incstar Corp.
- Clearance pathway: Traditional
- Review panel: Pathology
- Device class: Class I
- Regulation citation: 21 CFR 864.4010
- Decision date: 1996-07-24
Classification & Regulation
This clearance is catalogued under FDA product code IGC and 21 CFR 864.4010, within the Pathology review panel as a Class I device.