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Drx Ntx or, Osteomark Ntx Direct Response

by Metrika, Inc.

510(k) K984530

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK984530 Date10 Aug 1999ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
JFY
Device Class
Class II
Regulation
21 CFR Part 862.1225
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 Sep 2026

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

This device is an enzymatic method for creatinine measurement, classified under Clinical Chemistry. It is a diagnostic test system designed for the quantitative determination of creatinine in biological specimens.

The device is supplied as a reagent system for in vitro diagnostic use. It received traditional 510(k) clearance (K984530) from the FDA and is classified as a Class II medical device. It is intended for use in clinical laboratory settings by trained professionals.

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