G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE— 510(k) K020489

Name: FDA 510(k) clearance K020489
Creator: U.S. Food and Drug Administration
Published: 2002-05-14

Substantially Equivalent

Tosoh Medics, Inc.

FDA 510(k) clearance K020489 for G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE, Substantially Equivalent on 2002-05-14. Applicant: Tosoh Medics, Inc.. Device class: 2.

Clearance details

Applicant: Tosoh Medics, Inc.
Product code: Code JPD
Device class: Class 2
Regulation: 21 CFR 864.7400
Advisory panel: Hematology
Date received: 2002-02-13
Decision date: 2002-05-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: South San Francisco, CA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K020489

K-number listed on FDA's recall record

Z-1075-2013 — G7 HPLC. Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood.Class III·Terminated·Tosoh Bioscience Inc·20100818

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020489.

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