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D-10 220-0212

by Bio-Rad Laboratories

D-10 220-0212 (2200212) is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K041444 on 9 Jun 2004 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847817003462), 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

2 closed

Documents

510(k) K041444

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 Number00847817003462 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK041444 Date9 Jun 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K041444 decided 9 Jun 2004 Active
  • FDA GUDID UDI-DI 00847817003462 listed 12 Sep 2016 Listed

Recalls

2 recalls · FDA

    • Terminated Z-2889-2011 FDA Unclassified (pre-2012) initiated 11 Jul 2011

    Reports of calibration failure and late retention time using Elution Buffer AA10434 and AA10435.

    • Terminated Z-0376-2007 FDA Unclassified (pre-2012) initiated 17 Nov 2006 on shared 510(k) K041444

    The Diluent in the D-10 Dual Program Calibrator reorder packs is defective, and can cause early calibration failure or elevated control and sample recovery results.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

4 dated events

  1. Cleared FDA 510(k) K041444
  2. Recall initiated FDA recalls Z-0376-2007
  3. Recall initiated FDA recalls Z-2889-2011
  4. Listed FDA GUDID 00847817003462

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  • Withdrawn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
220-0212, 2200212
Primary DI / UDI-DI
00847817003462
510(k) Number
FDA product code
JPD, LCP
GMDN term
Glycated haemoglobin (HbA1c) IVD, reagent
Device class
Class II
Regulation number
864.7400, 864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Glycated haemoglobin (HbA1c) IVD, reagentHaemoglobin F (HbF) IVD, reagentHaemoglobin A2 (HbA2) IVD, reagent

Cleared under the same submission (K041444)

and 5 more cleared under K041444

Similar devices

Also classified as Haemoglobin A2 (HbA2) IVD, reagent.

Similar devices

Other devices filed under FDA product code JPD (HEMOGLOBIN A2 QUANTITATION).

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)