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Henry Schein 5701171

by Henry Schein, Inc.

Henry Schein 5701171 is a Class II device made by Henry Schein, Inc., cleared under FDA 510(k) K143325 on 20 Aug 2015 (1 earlier submission) and listed in FDA GUDID since 24 Feb 2020 (UDI-DI 10304040102524), active as of 23 Oct 2026. One FDA recall is linked to it.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10304040102524 UDI-DI Date24 Feb 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK143325 Date20 Aug 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K143325 decided 20 Aug 2015 Active· +1 more in the status table
  • FDA GUDID UDI-DI 10304040102524 listed 24 Feb 2020 Listed

Recalls

1 recall · FDA

    • Terminated Z-1059-2013 FDA Class II initiated 12 Feb 2013

    The test strips in the affected product lots of the OC Light immunological fecal occult blood test are being recalled because they may not be stable through their labeled shelf-life. There may be a possibility of obtaining false negative results when using the affected lots.

Timeline

4 dated events

  1. Cleared FDA 510(k) K041297
  2. Recall initiated FDA recalls Z-1059-2013
  3. Cleared FDA 510(k) K143325
  4. Listed FDA GUDID 10304040102524

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Henry Schein
Generic name
Faecal occult blood IVD, control
Model / Ref / Catalog
5701171
Primary DI / UDI-DI
10304040102524
510(k) Number
FDA product code
KHE
GMDN term
Faecal occult blood IVD, control
Device class
Class II
Regulation number
864.6550
GUDID distribution status
In Commercial Distribution

Related devices

Category: Faecal occult blood IVD, control

Cleared under the same submission (K041297)

Cleared under the same submission (K143325)

and 8 more cleared under K143325

Similar devices

Other devices filed under FDA product code KHE (REAGENT, OCCULT BLOOD).

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)