K780709Substantially Equivalent

In Vitro Gentamicin Radioimmunoassy Test

Name: K780709 In Vitro Gentamicin Radioimmunoassy Test
Creator: Clinical Assays, Inc.
Published: 1978-05-12
License: https://open.fda.gov/license/

Clinical Assays, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K780709 is the FDA 510(k) clearance record for IN VITRO GENTAMICIN RADIOIMMUNOASSY TEST, cleared for Clinical Assays, Inc. on 1978-05-12. FDA records list 27 510(k) clearances for Clinical Assays, Inc., from 1977-04-06 to 1983-10-04. As of 2026-09-10, FDA records show no recalls naming K780709.

Clearance record

Decision date: 1978-05-12
Received: 1978-04-26 (16 days to decision)
Review panel: Unknown
Applicant: Clinical Assays, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No