THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT— 510(k) K872217

Name: FDA 510(k) clearance K872217
Creator: U.S. Food and Drug Administration
Published: 1987-07-31

Substantially Equivalent

Pacific Hemostasis

FDA 510(k) clearance K872217 for THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT, Substantially Equivalent on 1987-07-31. Applicant: Pacific Hemostasis. Device class: 2.

Clearance details

Applicant: Pacific Hemostasis
Product code: Code GHM
Device class: Class 2
Regulation: 21 CFR 864.7825
Advisory panel: Hematology
Date received: 1987-06-09
Decision date: 1987-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, 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.