DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA— 510(k) K915411

Name: FDA 510(k) clearance K915411
Creator: U.S. Food and Drug Administration
Published: 1992-05-11

Substantially Equivalent

Baxter Diagnostics, Inc.

FDA 510(k) clearance K915411 for DADE IMMUNOADSORBED FACTOR IX DEFICIENT PLASMA, Substantially Equivalent on 1992-05-11. Applicant: Baxter Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Baxter Diagnostics, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1991-12-02
Decision date: 1992-05-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miami, FL, US

Download summary PDF View on FDA.gov ↗

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