K770467Substantially Equivalent

In Vitro Diagnostic Test

Name: K770467 In Vitro Diagnostic Test
Creator: Hoffmann-La Roche, Inc.
Published: 1977-04-27
License: https://open.fda.gov/license/

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

FDA source

K770467 is the FDA 510(k) clearance record for IN VITRO DIAGNOSTIC TEST, cleared for Hoffmann-La Roche, Inc. on 1977-04-27. 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 K770467.

Clearance record

Decision date: 1977-04-27
Received: 1977-03-10 (48 days to decision)
Review panel: Unknown
Applicant: Hoffmann-La Roche, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No