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Alere Reader EQ00600X

by Alere Scarborough, Inc.

Alere Reader EQ00600X is a device made by Alere Scarborough, Inc., cleared under FDA 510(k) K162642 on 10 Apr 2017 and listed in FDA GUDID since 28 Dec 2017 (UDI-DI 00811877010999), active as of 22 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 22 Oct 2026

Documents

510(k) K162642

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00811877010999 UDI-DI Date28 Dec 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK162642 Date10 Apr 2017DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K162642 decided 10 Apr 2017 Active
  • FDA GUDID UDI-DI 00811877010999 listed 28 Dec 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K162642
  2. Listed FDA GUDID 00811877010999

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Alere Reader
Generic name
Photometric/spectroscopic immunoassay analyser IVD
Model / reference
EQ00600X
Primary DI / UDI-DI
00811877010999
510(k) Number
GMDN term
Photometric/spectroscopic immunoassay analyser IVD
GUDID distribution status
In Commercial Distribution

Related devices

Category: Photometric/spectroscopic immunoassay analyser IVD

Cleared under the same submission (K162642)

and 1 more cleared under K162642

Other devices from Alere Scarborough, Inc.

See all devices from Alere Scarborough, Inc. →

Properties

  • Convenience kit
  • Serial number
Other properties (13, all answered No)