POSITIVE LUPUS ANTICOAGULANT PLASMA— 510(k) K945856

Name: FDA 510(k) clearance K945856
Creator: U.S. Food and Drug Administration
Published: 1995-10-05

Substantially Equivalent

George King Bio-Medical, Inc.

FDA 510(k) clearance K945856 for POSITIVE LUPUS ANTICOAGULANT PLASMA, Substantially Equivalent on 1995-10-05. Applicant: George King Bio-Medical, Inc.. Device class: 2.

Clearance details

Applicant: George King Bio-Medical, Inc.
Product code: Code GGC
Device class: Class 2
Regulation: 21 CFR 864.5425
Advisory panel: Hematology
Date received: 1994-11-14
Decision date: 1995-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Overland Park, KS, US

Download summary PDF View on FDA.gov ↗

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