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JAS Diagnostics IRO2-BUL

by Drew Scientific, Ltd.

JAS Diagnostics IRO2-BUL is a Class I device made by Drew Scientific, Ltd., cleared under FDA 510(k) K864882 on 21 Jan 1987 and listed in FDA GUDID since 9 Sep 2016 (UDI-DI 00817274021781), active as of 22 Oct 2026. 8 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

8 closed

Documents

510(k) K864882

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 Number00817274021781 UDI-DI Date9 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK864882 Date21 Jan 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K864882 decided 21 Jan 1987 Active
  • FDA GUDID UDI-DI 00817274021781 listed 9 Sep 2016 Listed

Recalls

8 recalls · FDA

  • 8 recalls, same reason

    • Terminated Z-0902-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0905-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0899-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0903-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0901-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0906-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0900-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009
    • Terminated Z-0904-2010 FDA Unclassified (pre-2012) initiated 16 Nov 2009

    Turbidity formation could occur, resulting in invalid test results being reported out.

Timeline

10 dated events

  1. Cleared FDA 510(k) K864882
  2. Recall initiated FDA recalls Z-0902-2010
  3. Recall initiated FDA recalls Z-0905-2010
  4. Recall initiated FDA recalls Z-0899-2010
  5. Recall initiated FDA recalls Z-0903-2010
  6. Recall initiated FDA recalls Z-0901-2010
  7. Recall initiated FDA recalls Z-0906-2010
  8. Recall initiated FDA recalls Z-0900-2010
  9. Recall initiated FDA recalls Z-0904-2010
  10. Listed FDA GUDID 00817274021781

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
JAS Diagnostics
Generic name
Total iron binding capacity IVD (TIBC), reagent
Model / reference
IRO2-BUL
Primary DI / UDI-DI
00817274021781
510(k) Number
FDA product code
JIY
GMDN term
Total iron binding capacity IVD (TIBC), reagent
Device class
Class I
Regulation number
862.1410
GUDID distribution status
In Commercial Distribution

Related devices

Category: Total iron binding capacity IVD (TIBC), reagent

Cleared under the same submission (K864882)

and 8 more cleared under K864882

Similar devices

Other devices filed under FDA product code JIY (Photometric Method, Iron (Non-Heme)).

Other devices from Drew Scientific, Ltd.

See all devices from Drew Scientific, Ltd. →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)