PHOSPHOLIN ES AND CALCIUM CHLORIDE— 510(k) K033471

Name: FDA 510(k) clearance K033471
Creator: U.S. Food and Drug Administration
Published: 2004-02-04

Substantially Equivalent

R2 Diagnostics, Inc.

FDA 510(k) clearance K033471 for PHOSPHOLIN ES AND CALCIUM CHLORIDE, Substantially Equivalent on 2004-02-04. Applicant: R2 Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: R2 Diagnostics, Inc.
Product code: Code GGW
Device class: Class 2
Regulation: 21 CFR 864.7925
Advisory panel: Hematology
Date received: 2003-11-03
Decision date: 2004-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South Bend, IN, US

Download summary PDF View on FDA.gov ↗

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