Skip to content

Eocene System

by Infopia Co, Ltd.

510(k) K090712

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK090712 Date2 Oct 2009ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
NBW
Device Class
Class II
Regulation
21 CFR Part 862.1345
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Eocene System is a device in the Clinical Chemistry category, as indicated by the advisory committee classification. It received FDA 510(k) clearance as substantially equivalent to a legally marketed device.

The system was cleared through a special 510(k) process and is manufactured by Infopia Co, Ltd. It is identified by the product code NBW and k-number K090712, with authorization granted on October 2, 2009.

Other devices from Infopia Co, Ltd.

See all devices from Infopia Co, Ltd. →

Questions

AI-generated answers, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Eocene System used for?

    The Eocene System is classified under the Clinical Chemistry category by the FDA advisory committee, indicating its use in clinical laboratory settings for analyzing chemical components in bodily fluids to aid in diagnosis and monitoring of medical conditions.

  • How is the Eocene System supplied and is it sterile or single-use?

    The device data does not specify supply format, sterility, or single-use/reuse status for the Eocene System; such details would typically be found in the device’s labeling or instructions for use, which are not included in the provided authorization records.

  • What regulatory pathway was used for the Eocene System and what does its clearance mean?

    The Eocene System received FDA 510(k) clearance through a special 510(k) process, meaning it was determined to be substantially equivalent to a legally marketed predicate device, allowing it to be legally marketed in the U.S. for its intended use.