K760396Substantially Equivalent

Test, Macroglobulin Kit (Alpha2)

Name: K760396 Test, Macroglobulin Kit (Alpha2)
Creator: Kallestad Laboratories, Inc.
Published: 1976-08-26
License: https://open.fda.gov/license/

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

FDA source

K760396 is the FDA 510(k) clearance record for TEST, MACROGLOBULIN KIT (ALPHA2), cleared for Kallestad Laboratories, Inc. on 1976-08-26. 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 K760396.

Clearance record

Decision date: 1976-08-26
Received: 1976-08-06 (20 days to decision)
Review panel: Unknown
Applicant: Kallestad Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No