K863065Substantially Equivalent

Hdl Cholesterol-E

Name: K863065 Hdl Cholesterol-E
Creator: J. D. Assoc.
Published: 1986-09-25
License: https://open.fda.gov/license/

J. D. Assoc., Montclair NJ / Traditional, Substantially Equivalent

FDA source

K863065 is the FDA 510(k) clearance record for HDL CHOLESTEROL-E, cleared for J. D. Assoc. on 1986-09-25. FDA records list 34 510(k) clearances for J. D. Assoc., from 1986-09-04 to 1987-01-13. As of 2026-09-10, FDA records show no recalls naming K863065.

Clearance record

Decision date: 1986-09-25
Received: 1986-08-12 (44 days to decision)
Review panel: Unknown
Applicant: J. D. Assoc. 163 Montclair Ave., Montclair NJ
Third party review: No