PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056)— 510(k) K972627

Name: FDA 510(k) clearance K972627
Creator: U.S. Food and Drug Administration
Published: 1997-08-13

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K972627 for PACIFIC HEMOSTASIS IMMUNODEPLETED FACTOR V DEFICIENT PLASMA (THROMBOSDREEN BRAND) (100056), Substantially Equivalent on 1997-08-13. 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: 1997-07-14
Decision date: 1997-08-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Huntersville, NC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.