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Selectra ProM

by ELITechGroup B.V. GUDID

Withdrawn United States

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03661540600401 UDI-DIDate18 Nov 2016ListedStatusWithdrawn

Coverage

1 jurisdiction

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

United States — GUDID listing Listed

Recalls

4 recalls · FDA

    • Terminated Z-2764-2019 FDA Class III initiated 12 Jul 2016 via K102647, on the same 510(k)

    Software malfunction; The action being taken due to the device becoming inoperable due to software lockup.

    • Terminated Z-0006-2015 FDA Class III initiated 11 Aug 2014 via K102647, on the same 510(k)

    Some users of ENVOY 500 AST Reagent Kit, reference 55255, for Envoy 500 systems are observing that Quality Control (QC) fails before the product expiry is reached.

  • 2 recalls, same reason

    • Terminated Z-0158-2020 FDA Class II initiated 10 Jan 2012
    • Terminated Z-0157-2020 FDA Class II initiated 10 Jan 2012

    The action was initiated due power supply failure. During a power supply failure the instruments malfunctions and no patient results are produced.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID

Trade Name
Selectra
Generic Name
Multiple clinical chemistry analyser IVD, laboratory, semi-automated
Model / Ref / Catalog
ProM, 6003-436
Primary DI / UDI-DI
03661540600401
510(k) Number
FDA Product Code
JGS
GMDN Term
Multiple clinical chemistry analyser IVD, laboratory, semi-automated
Device Class
Class II
Regulation Number
862.1665
Commercial Distribution
Not in Commercial Distribution

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No