TOTAL PROTEIN (URINE)— 510(k) K951222

Name: FDA 510(k) clearance K951222
Creator: U.S. Food and Drug Administration
Published: 1996-04-24

Substantially Equivalent

Randox Laboratories, Ltd.

FDA 510(k) clearance K951222 for TOTAL PROTEIN (URINE), Substantially Equivalent on 1996-04-24. Applicant: Randox Laboratories, Ltd.. Device class: 1.

Clearance details

Applicant: Randox Laboratories, Ltd.
Product code: Code JIR
Device class: Class 1
Regulation: 21 CFR 862.1645
Advisory panel: Clinical Chemistry
Date received: 1995-03-20
Decision date: 1996-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Crumlin, IE

Download summary PDF View on FDA.gov ↗

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