TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE— 510(k) K852611

Name: FDA 510(k) clearance K852611
Creator: U.S. Food and Drug Administration
Published: 1985-09-03

Substantially Equivalent

Miles Laboratories, Inc.

FDA 510(k) clearance K852611 for TEST UROBILINOGEN IN URINE & LEUKOCYTES IN URINE, Substantially Equivalent on 1985-09-03. Applicant: Miles Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Miles Laboratories, Inc.
Product code: Code CDM
Device class: Class 1
Regulation: 21 CFR 862.1785
Advisory panel: Clinical Chemistry
Date received: 1985-06-19
Decision date: 1985-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhart, IN, US

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