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Dimension Exl N-Ternmial Pro-Brain Natriuretic Peptide (Ntp) Flex Reagent Cartridge, Model RF623

by Siemens Healthcare Diagnostics

510(k) K082645

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 10 Oct 2026. What this means

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK082645 Date22 Sep 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0461-2011 FDA Unclassified (pre-2012) initiated 12 Apr 2010

    Some LOCI cartridges have sub-optimal seal of the lidstock that can cause rupture of the package at high elevations, causing the cartridge to leak. Use of leaking cartridges may result in inaccurate test results.

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  • Withdrawn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
NBC
Device Class
Class II
Regulation
21 CFR Part 862.1117
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

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