K842965Substantially Equivalent

Gastrin Radioimmunoassay Test Kit

Name: K842965 Gastrin Radioimmunoassay Test Kit
Creator: Serono Diagnostics, Inc.
Published: 1984-10-11
License: https://open.fda.gov/license/

Serono Diagnostics, Inc., Bramtree MA / Traditional, Substantially Equivalent

FDA source

K842965 is the FDA 510(k) clearance record for GASTRIN RADIOIMMUNOASSAY TEST KIT, cleared for Serono Diagnostics, Inc. on 1984-10-11. FDA records list 25 510(k) clearances for Serono Diagnostics, Inc., from 1984-04-13 to 1996-03-11. As of 2026-09-10, FDA records show no recalls naming K842965.

Clearance record

Decision date: 1984-10-11
Received: 1984-07-27 (76 days to decision)
Review panel: Unknown
Applicant: Serono Diagnostics, Inc. 11 Brooks Dr., Bramtree MA
Third party review: No