CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA— 510(k) K924400

Name: FDA 510(k) clearance K924400
Creator: U.S. Food and Drug Administration
Published: 1993-06-08

Substantially Equivalent

Behring Diagnostics, Inc.

FDA 510(k) clearance K924400 for CLOTTING FACTOR-11,-VII, -X DEFICIENT PLASMA, Substantially Equivalent on 1993-06-08. Applicant: Behring Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Behring Diagnostics, Inc.
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1992-08-31
Decision date: 1993-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Somerville, NJ, US

Download summary PDF View on FDA.gov ↗

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