K852747Substantially Equivalent

Visidex II Reagent Strips

Name: K852747 Visidex II Reagent Strips
Creator: Miles Laboratories, Inc.
Published: 1985-08-12
License: https://open.fda.gov/license/

Miles Laboratories, Inc., Elkhart IN / Traditional, Substantially Equivalent

FDA source

K852747 is the FDA 510(k) clearance record for VISIDEX II REAGENT STRIPS, cleared for Miles Laboratories, Inc. on 1985-08-12. FDA records list 158 510(k) clearances for Miles Laboratories, Inc., from 1976-08-30 to 1988-05-26. As of 2026-09-10, FDA records show no recalls naming K852747.

Clearance record

Decision date: 1985-08-12
Received: 1985-06-27 (46 days to decision)
Review panel: Unknown
Applicant: Miles Laboratories, Inc. 1127 Myrtle St., Elkhart IN
Third party review: No