Skip to content

ST AIA-PACK hsE2 Calibrator Set

by Tosoh Bioscience, Inc.

510(k) K160113

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 27 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 27 Oct 2026. What this means

Regulatory status

as of registry sync 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK160113 Date17 Feb 2016ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 27 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  • Withdrawn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
JIT
Device Class
Class II
Regulation
21 CFR Part 862.1150
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 27 Oct 2026

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

The ST AIA-PACK hsE2 Calibrator Set is a secondary calibrator. This device is associated with 510(k) K160113, which is a clearance decided on 2016-02-17 for a Class II device under product code JIT and regulation 862.1150.

Other devices from Tosoh Bioscience, Inc.

See all devices from Tosoh Bioscience, Inc. →