Clearance Summary
MID-LEVEL IGG KIT CAT. NO. 9315 received FDA 510(k) clearance under submission number K891299, sponsored by Helena Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1989-03-22.
- Submission: K891299
- Applicant / Sponsor: Helena Laboratories
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5540
- Decision date: 1989-03-22
Classification & Regulation
This clearance is catalogued under FDA product code DAQ and 21 CFR 866.5540, within the Immunology review panel as a Class I device.