URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE— 510(k) K860143

Name: FDA 510(k) clearance K860143
Creator: U.S. Food and Drug Administration
Published: 1986-02-10

Substantially Equivalent

Reagent Laboratory, Inc.

FDA 510(k) clearance K860143 for URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODE, Substantially Equivalent on 1986-02-10. Applicant: Reagent Laboratory, Inc.. Device class: 1.

Clearance details

Applicant: Reagent Laboratory, Inc.
Product code: Code JJP
Device class: Class 1
Regulation: 21 CFR 862.2050
Advisory panel: Clinical Chemistry
Date received: 1986-01-15
Decision date: 1986-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Louisville, KY, US

Download summary PDF View on FDA.gov ↗

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