Clearance Summary
ACETAMINOPHEN (ENZYMATIC RATE), NUMBER 502-13 received FDA 510(k) clearance under submission number K885097, sponsored by Diagnostic Chemicals, Ltd. (Usa). The device was reviewed via the Traditional premarket notification pathway and assigned to the Clinical Toxicology review panel. The statutory decision date of record is 1989-01-11.
- Submission: K885097
- Applicant / Sponsor: Diagnostic Chemicals, Ltd. (Usa)
- Clearance pathway: Traditional
- Review panel: Clinical Toxicology
- Device class: Class II
- Regulation citation: 21 CFR 862.3030
- Decision date: 1989-01-11
Classification & Regulation
This clearance is catalogued under FDA product code LDP and 21 CFR 862.3030, within the Clinical Toxicology review panel as a Class II device.