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Modification to: Unicap Specific Ige

by Pharmacia Diagnostics AB

510(k) K051218

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 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 NumberK051218 Date9 Jun 2005ClearedStatusActive

Recalls

3 recalls · FDA

    • Terminated Z-2397-2019 FDA Class II initiated 9 Jul 2019

    code 7-102 Liquid Sensor Error

    • Terminated Z-1312-2018 FDA Class II initiated 18 Dec 2017

    The stability specifications of ImmunoCAP Allergen c5, Ampicilloyl were not met.

    • Terminated Z-1313-2018 FDA Class II initiated 18 Dec 2017

    The stability specifications of ImmunoCAP Allergen c6, Amoxicilloyl were not met.

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  • Withdrawn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
DHB
Device Class
Class II
Regulation
21 CFR Part 866.5750
Advisory Committee
Immunology
FDA Decision
SESE Substantially Equivalent

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