K801565Substantially Equivalent

Cybrex Phenytoin

Name: K801565 Cybrex Phenytoin
Creator: Abbott Laboratories
Published: 1980-07-21
License: https://open.fda.gov/license/

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent

FDA source

K801565 is the FDA 510(k) clearance record for CYBREX PHENYTOIN, cleared for Abbott Laboratories on 1980-07-21. FDA records list 1,478 510(k) clearances for Abbott Medical, from 1976-09-16 to 2026-07-15. As of 2026-09-10, FDA records show no recalls naming K801565.

Clearance record

Decision date: 1980-07-21
Received: 1980-07-08 (13 days to decision)
Review panel: Unknown
Applicant: Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review: No