K760089Substantially Equivalent

Test, in-Vitro Diagnostic

Name: K760089 Test, in-Vitro Diagnostic
Creator: Hoffmann-La Roche, Inc.
Published: 1976-07-20
License: https://open.fda.gov/license/

Hoffmann-La Roche, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K760089 is the FDA 510(k) clearance record for TEST, IN-VITRO DIAGNOSTIC, cleared for Hoffmann-La Roche, Inc. on 1976-07-20. FDA records list 49 510(k) clearances for Hoffmann-La Roche, Inc., from 1976-07-20 to 1985-06-25. As of 2026-09-10, FDA records show no recalls naming K760089.

Clearance record

Decision date: 1976-07-20
Received: 1976-06-21 (29 days to decision)
Review panel: Unknown
Applicant: Hoffmann-La Roche, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No