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Cobas Ready Calibrator Kit

by Roche Diagnostic Systems, Inc.

510(k) K897097

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 NumberK897097 Date26 Jun 1990ClearedStatusActive

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  • Withdrawn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, 22 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 Cobas Ready Calibrator Kit is a multi-analyte mixture used as a calibrator for clinical chemistry analyzers. It consists of a liquid, ready-for-use buffered aqueous solution designed to ensure optimal calibration of appropriate Roche methods.

This device is supplied for use in clinical chemistry settings. It is regulated under FDA 510(k) clearance, identified by submission number K897097.

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