Clearance Summary
DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA received FDA 510(k) clearance under submission number K920895, sponsored by Baxter Diagnostics, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Hematology review panel. The statutory decision date of record is 1992-06-04.
- Submission: K920895
- Applicant / Sponsor: Baxter Diagnostics, Inc.
- Clearance pathway: Traditional
- Review panel: Hematology
- Device class: Class II
- Regulation citation: 21 CFR 864.7320
- Decision date: 1992-06-04
Classification & Regulation
This clearance is catalogued under FDA product code MIF and 21 CFR 864.7320, within the Hematology review panel as a Class II device.