Clearance Summary
ENZIP IMMUNOTURBIDIMETRIC MICROALBUMIN ASSAY KIT received FDA 510(k) clearance under submission number K971458, sponsored by Diagnostic Specialties. 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 1997-09-02.
- Submission: K971458
- Applicant / Sponsor: Diagnostic Specialties
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1645
- Decision date: 1997-09-02
Classification & Regulation
This clearance is catalogued under FDA product code JIQ and 21 CFR 862.1645, within the Clinical Chemistry review panel as a Class I device.