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CardioChek 5700412

by Henry Schein, Inc.

CardioChek 5700412 is a Class I device made by Henry Schein, Inc., cleared under FDA 510(k) K140068 on 22 May 2015 (2 earlier submissions) and listed in FDA GUDID since 5 Jan 2017 (UDI-DI 10304040037734), active as of 23 Oct 2026. 6 FDA recalls are 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

6 closed

Documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10304040037734 UDI-DI Date5 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK140068 Date22 May 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140068 decided 22 May 2015 Active· +2 more in the status table
  • FDA GUDID UDI-DI 10304040037734 listed 5 Jan 2017 Listed

Recalls

6 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-0833-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0835-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0834-2020 FDA Class II initiated 2 Dec 2019
    • Terminated Z-0832-2020 FDA Class II initiated 2 Dec 2019

    One brand of batteries have a small dimensional difference in the negative button terminal, which, when the batteries are inserted incorrectly, can create the possibility for the battery terminals to make reverse contact. This reverse contact can cause a potential for overheating.

    • Terminated Z-1372-2019 FDA Class II initiated 16 Jan 2019

    Some lots of test strips do not fit tightly into the optical block, and may fall out during analysis, which could lead to an incorrect result being di P832 Chemistry (Diagnostic) CHH 2 Lipid Panel test strips (as a component of smart bundles), REF 2729, also private labeled under Henry Schein as REF 570-0412

    • Terminated Z-1136-2010 FDA Unclassified (pre-2012) initiated 5 Jun 2009

    Exhibits under-recovery of all analytes.

Timeline

10 dated events

  1. Cleared FDA 510(k) K022898
  2. Cleared FDA 510(k) K023558
  3. Recall initiated FDA recalls Z-1136-2010
  4. Cleared FDA 510(k) K140068
  5. Listed FDA GUDID 10304040037734
  6. Recall initiated FDA recalls Z-1372-2019
  7. Recall initiated FDA recalls Z-0833-2020
  8. Recall initiated FDA recalls Z-0835-2020
  9. Recall initiated FDA recalls Z-0834-2020
  10. Recall initiated FDA recalls Z-0832-2020

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
CardioChek
Generic name
Multiple lipid analyte IVD, kit, multiple technologies
Model / Ref / Catalog
5700412
Primary DI / UDI-DI
10304040037734
510(k) Number
FDA product code
LBR, NBW, CHH, CGA, JGY
GMDN term
Multiple lipid analyte IVD, kit, multiple technologies
Device class
Class I
Regulation number
862.1475, 862.1345, 862.1175, 862.1705
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple lipid analyte IVD, kit, multiple technologiesMultiple clinical chemistry enzyme IVD, kit, spectrophotometry

Cleared under the same submission (K022898)

Cleared under the same submission (K023558)

Other devices from Henry Schein, Inc.

See all devices from Henry Schein, Inc. →

Properties

  • Single use
  • Prescription use
  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)