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Referril Calibrators

by Instrumentation Laboratory CO

510(k) K844585

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 · Traditional NumberK844585 Date11 Dec 1984ClearedStatusActive

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  • Withdrawn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
JIX
Device class
Class II
Regulation
21 CFR Part 862.1150
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.

Referril Calibrators are multi-analyte mixture calibrators used in clinical chemistry laboratories. These devices are designed to provide reference values for various analytes to ensure accurate calibration of laboratory instruments.

The Referril Calibrators are supplied by Instrumentation Laboratory CO and are classified as Class II medical devices under product code JIX. They are regulated under FDA 510(k) clearance K844585, which was issued on December 11, 1984, with a decision code of SESE (Substantially Equivalent).

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