Cleared Traditional

G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE

K020489 · Tosoh Medics, Inc. · Hematology
May 2002
Decision
90d
Days
Class 2
Risk

About This 510(k) Submission

K020489 is an FDA 510(k) clearance for the G7 AUTOMATED HPLC ANALYZER, BETA-THALASSEMIA MODE, a Hemoglobin A2 Quantitation (Class II — Special Controls, product code JPD), submitted by Tosoh Medics, Inc. (South San Francisco, US). The FDA issued a Cleared decision on May 14, 2002, 90 days after receiving the submission on February 13, 2002. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7400.

Submission Details

510(k) Number K020489 FDA.gov
FDA Decision Cleared SESE
Date Received February 13, 2002
Decision Date May 14, 2002
Days to Decision 90 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPD — Hemoglobin A2 Quantitation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7400

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