Skip to content

Dimension Vista Dbil Flex Reagent Cartridge, Model K2125

by Dade Behring, Inc. 510(k)

Active United States

510(k) K061839

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061839 Date29 Aug 2006ClearedStatusActive

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
CIG
Device Class
Class II
Regulation
21 CFR Part 862.1110
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Dade Behring, Inc.

See all devices from Dade Behring, Inc. →