Clearance Summary
SPQ MALB CONTROL LEVEL II received FDA 510(k) clearance under submission number K934521, sponsored by Incstar Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Chemistry review panel. The statutory decision date of record is 1993-11-26.
- Submission: K934521
- Applicant / Sponsor: Incstar Corp.
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1660
- Decision date: 1993-11-26
Classification & Regulation
This clearance is catalogued under FDA product code JJX and 21 CFR 862.1660, within the Clinical Chemistry review panel as a Class I device.