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D-10 220-0109

by Bio-Rad Laboratories

D-10 220-0109 (2200109) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K031043 on 27 Aug 2003 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817003271), 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

510(k) K031043

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 Number00847817003271 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK031043 Date27 Aug 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K031043 decided 27 Aug 2003 Active
  • FDA GUDID UDI-DI 00847817003271 listed 12 Sep 2016 Listed

Recalls

6 recalls · FDA

    • Terminated Z-1299-2014 FDA Class II initiated 27 Feb 2014

    On a rare occasion the D-10 software might generate an extra result by duplicating the result form the previous sample and the Sample ID/Injection number from the next sample.

    • Terminated Z-0965-2014 FDA Class III initiated 22 Nov 2013

    D-10 A1c Dual Program Floppy was programmed incorrectly and cartridge injections counts are not being updated correctly when switching between the D-10 Dual Short Program and Extended Program on the D-10 Hemoglobin Testing System.

  • 3 recalls, same reason

    • Terminated Z-0017-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011
    • Terminated Z-0019-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011
    • Terminated Z-0018-2012 FDA Unclassified (pre-2012) initiated 12 Sep 2011

    A previous recall related to reports of calibration failure and late retention times using Elution Buffer led to an examination of other buffers manufactured during the same time period and a decision was made to field correct these products until a definitive root cause and corrective action have been found and implemented.

    • Terminated Z-1969-2011 FDA Unclassified (pre-2012) initiated 8 Sep 2010

    The firm discovered that the Update Kit Floppy Diskette included in the reorder pack was mislabeled with an incorrect Lot Number for the Calibrator/Diluent Set as: S01819; The correct Lot Number for the Calibrator/Diluent Set is: S01704.

Timeline

8 dated events

  1. Cleared FDA 510(k) K031043
  2. Recall initiated FDA recalls Z-1969-2011
  3. Recall initiated FDA recalls Z-0017-2012
  4. Recall initiated FDA recalls Z-0019-2012
  5. Recall initiated FDA recalls Z-0018-2012
  6. Recall initiated FDA recalls Z-0965-2014
  7. Recall initiated FDA recalls Z-1299-2014
  8. Listed FDA GUDID 00847817003271

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
D-10
Generic name
Glycated haemoglobin (HbA1c) IVD, reagent
Model / Ref / Catalog
220-0109, 2200109
Primary DI / UDI-DI
00847817003271
510(k) Number
FDA product code
LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagent

Cleared under the same submission (K031043)

and 3 more cleared under K031043

Similar devices in this category

Other devices filed under Glycated haemoglobin (HbA1c) IVD, reagent.

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (11, all answered No)