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Elia Ccp, Model 14-5515-01; Elia Ccp Control, Model 83-1009-01

by Sweden Diagnostics (Us), Inc.

510(k) K061165

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK061165 Date3 Aug 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1253-2017 FDA Class II initiated 30 Jan 2017

    Erroneous EliA test results related to problems with liquid level detection and diluent pipetting in Phadia 250 instruments, and deformed bottles. Investigation showed problems with the liquid level detection in diluent bottle batch JJCA resulting in aspiration of no or too low volumes of liquid from the diluent bottle and from the dilution plate.

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  • Withdrawn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
NHX
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 866.5775
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent