K770965Substantially Equivalent

Human Reference Serum

Name: K770965 Human Reference Serum
Creator: Kallestad Laboratories, Inc.
Published: 1977-06-22
License: https://open.fda.gov/license/

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

FDA source

K770965 is the FDA 510(k) clearance record for HUMAN REFERENCE SERUM, cleared for Kallestad Laboratories, Inc. on 1977-06-22. FDA records list 92 510(k) clearances for Kallestad Laboratories, Inc., from 1976-07-26 to 1986-12-03. As of 2026-09-10, FDA records show no recalls naming K770965.

Clearance record

Decision date: 1977-06-22
Received: 1977-05-27 (26 days to decision)
Review panel: Unknown
Applicant: Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No