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Iron Standard Kit 9060

by Verichem Laboratories, Inc.

Iron Standard Kit 9060 is a Class II device made by Verichem Laboratories, Inc., cleared under FDA 510(k) K972333 on 23 Jul 1997 and listed in FDA GUDID since 17 Jan 2018 (UDI-DI 00852553007353), active as of 22 Oct 2026. 5 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

5 closed

Documents

510(k) K972333

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 Number00852553007353 UDI-DI Date17 Jan 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK972333 Date23 Jul 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K972333 decided 23 Jul 1997 Active
  • FDA GUDID UDI-DI 00852553007353 listed 17 Jan 2018 Listed

Recalls

5 recalls · FDA

    • Terminated Z-0743-2007 FDA Unclassified (pre-2012) initiated 20 Sep 2006

    Potential for microorganism growth in the alcohol standard and or unexpected QC changes in the Ammonia portion of the Ammonia/Alcohol control product.

  • 4 recalls, same reason

    • Terminated Z-1546-06 FDA Unclassified (pre-2012) initiated 9 Jun 2006
    • Terminated Z-1547-06 FDA Unclassified (pre-2012) initiated 9 Jun 2006
    • Terminated Z-1548-06 FDA Unclassified (pre-2012) initiated 9 Jun 2006
    • Terminated Z-1543-06 FDA Unclassified (pre-2012) initiated 9 Jun 2006

    Open vial stability-Potential microbial growth in the alcohol standard and possible unexpected QC changes in the ammonia portion of the control due to the lack of validation for long-term open vial stability.

Timeline

7 dated events

  1. Cleared FDA 510(k) K972333
  2. Recall initiated FDA recalls Z-1546-06
  3. Recall initiated FDA recalls Z-1547-06
  4. Recall initiated FDA recalls Z-1548-06
  5. Recall initiated FDA recalls Z-1543-06
  6. Recall initiated FDA recalls Z-0743-2007
  7. Listed FDA GUDID 00852553007353

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Iron Standard Kit
Generic name
Iron IVD, calibrator
Model / reference
9060
Primary DI / UDI-DI
00852553007353
510(k) Number
FDA product code
JIX
GMDN term
Iron IVD, calibrator
Device class
Class II
Regulation number
862.1150
GUDID distribution status
In Commercial Distribution

Related devices

Category: Iron IVD, calibrator

Cleared under the same submission (K972333)

Other devices from Verichem Laboratories, Inc.

See all devices from Verichem Laboratories, Inc. →

Properties

  • Lot / batch number
  • Expiration date
Other properties (13, all answered No)