Cleared Traditional

DIRECT TIBC KIT

K000781 · Reference Diagnostics, Inc. · Chemistry
May 2000
Decision
53d
Days
Class 1
Risk

About This 510(k) Submission

K000781 is an FDA 510(k) clearance for the DIRECT TIBC KIT, a Ferrozine (colorimetric) Iron Binding Capacity (Class I — General Controls, product code JMO), submitted by Reference Diagnostics, Inc. (Bedford, US). The FDA issued a Cleared decision on May 2, 2000, 53 days after receiving the submission on March 10, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1415.

Submission Details

510(k) Number K000781 FDA.gov
FDA Decision Cleared SESE
Date Received March 10, 2000
Decision Date May 02, 2000
Days to Decision 53 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JMO — Ferrozine (colorimetric) Iron Binding Capacity
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1415

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