Clearance Summary
STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAY received FDA 510(k) clearance under submission number K873052, sponsored by American Dade. 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 1987-09-14.
- Submission: K873052
- Applicant / Sponsor: American Dade
- Clearance pathway: Traditional
- Review panel: Clinical Chemistry
- Device class: Class I
- Regulation citation: 21 CFR 862.1485
- Decision date: 1987-09-14
Classification & Regulation
This clearance is catalogued under FDA product code CEP and 21 CFR 862.1485, within the Clinical Chemistry review panel as a Class I device.