Clearance Summary
SPQ(TM) TEST SYSTEM FOR PREALBUMIN received FDA 510(k) clearance under submission number K884297, sponsored by Atlantic Antibodies. The device was reviewed via the Traditional premarket notification pathway and assigned to the Immunology review panel. The statutory decision date of record is 1988-11-02.
- Submission: K884297
- Applicant / Sponsor: Atlantic Antibodies
- Clearance pathway: Traditional
- Review panel: Immunology
- Device class: Class I
- Regulation citation: 21 CFR 866.5060
- Decision date: 1988-11-02
Classification & Regulation
This clearance is catalogued under FDA product code JZJ and 21 CFR 866.5060, within the Immunology review panel as a Class I device.