PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA— 510(k) K990046

Name: FDA 510(k) clearance K990046
Creator: U.S. Food and Drug Administration
Published: 1999-02-17

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K990046 for PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR VIII DEFICIENT PLASMA, Substantially Equivalent on 1999-02-17. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GJT
Device class: Class 2
Regulation: 21 CFR 864.7290
Advisory panel: Hematology
Date received: 1999-01-07
Decision date: 1999-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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