K780372Substantially Equivalent

Cre. Phosphokinase Isoenzymes, Rea. Sys.

Name: K780372 Cre. Phosphokinase Isoenzymes, Rea. Sys.
Creator: Abbott Laboratories
Published: 1978-05-03
License: https://open.fda.gov/license/

Abbott Medical, Abbott Park IL / Traditional, Substantially Equivalent

FDA source

K780372 is the FDA 510(k) clearance record for CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS., cleared for Abbott Laboratories on 1978-05-03. 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 K780372.

Clearance record

Decision date: 1978-05-03
Received: 1978-03-08 (56 days to decision)
Review panel: Unknown
Applicant: Abbott Laboratories One Abbott Park Rd., Abbott Park IL
Third party review: No