HEMASPINNER— 510(k) K811534

Name: FDA 510(k) clearance K811534
Creator: U.S. Food and Drug Administration
Published: 1981-08-18

Substantially Equivalent

Geometric Data, Div. Smithkline Corp.

FDA 510(k) clearance K811534 for HEMASPINNER, Substantially Equivalent on 1981-08-18. Applicant: Geometric Data, Div. Smithkline Corp.. Device class: 1.

Clearance details

Applicant: Geometric Data, Div. Smithkline Corp.
Product code: Code GKJ
Device class: Class 1
Regulation: 21 CFR 864.5850
Advisory panel: Hematology
Date received: 1981-06-01
Decision date: 1981-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K791108 — CONTEXT FILTER1979-07-17
K790042 — STAIN, HEMASTAIN RETIC1979-02-15

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