K820005Substantially Equivalent

Total Hemolytic Complement Test Kit

Name: K820005 Total Hemolytic Complement Test Kit
Creator: Meloy Laboratories, Inc.
Published: 1982-01-22
License: https://open.fda.gov/license/

Meloy Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K820005 is the FDA 510(k) clearance record for TOTAL HEMOLYTIC COMPLEMENT TEST KIT, cleared for Meloy Laboratories, Inc. on 1982-01-22. FDA records list 15 510(k) clearances for Meloy Laboratories, Inc., from 1977-08-04 to 1985-06-21. As of 2026-09-10, FDA records show no recalls naming K820005.

Clearance record

Decision date: 1982-01-22
Received: 1982-01-04 (18 days to decision)
Review panel: Unknown
Applicant: Meloy Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No