K770062Substantially Equivalent

Gdh-Glucose (Rate) Reagent Kit

Name: K770062 Gdh-Glucose (Rate) Reagent Kit
Creator: Beckman Instruments, Inc.
Published: 1977-01-26
License: https://open.fda.gov/license/

Beckman Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent

FDA source

K770062 is the FDA 510(k) clearance record for GDH-GLUCOSE (RATE) REAGENT KIT, cleared for Beckman Instruments, Inc. on 1977-01-26. FDA records list 281 510(k) clearances for Beckman Instruments, Inc., from 1976-11-01 to 1998-09-17. As of 2026-09-10, FDA records show no recalls naming K770062.

Clearance record

Decision date: 1977-01-26
Received: 1977-01-11 (15 days to decision)
Review panel: Unknown
Applicant: Beckman Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review: No