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Vysis 04N02-020

by Abbott Molecular

Vysis 04N02-020 is a Class II device made by Abbott Molecular, cleared under FDA 510(k) K100015 on 9 Aug 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00884999007772), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K100015

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00884999007772 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK100015 Date9 Aug 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100015 decided 9 Aug 2011 Active
  • FDA GUDID UDI-DI 00884999007772 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100015
  2. Listed FDA GUDID 00884999007772

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vysis
Generic name
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Model / Ref / Catalog
04N02-020
Primary DI / UDI-DI
00884999007772
510(k) Number
FDA product code
OVQ
GMDN term
Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe
Device class
Class II
Regulation number
866.6040
GUDID distribution status
In Commercial Distribution

Related devices

Category: Chronic lymphocytic leukaemia (CLL) genetic mutation IVD, probe

Other devices from Abbott Molecular

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Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)