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i-STAT 02R29-03

by Abbott Point of Care Inc.

i-STAT 02R29-03 is a Class I device made by Abbott Point of Care Inc., cleared under FDA 510(k) K121237 on 18 May 2012 and listed in FDA GUDID since 23 Jun 2023 (UDI-DI 00054749002573), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K121237

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 Number00054749002573 UDI-DI Date23 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK121237 Date18 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K121237 decided 18 May 2012 Active
  • FDA GUDID UDI-DI 00054749002573 listed 23 Jun 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K121237
  2. Listed FDA GUDID 00054749002573

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
i-STAT
Generic name
Human chorionic gonadotropin beta-core fragment IVD, control
Model / Ref / Catalog
02R29-03
Primary DI / UDI-DI
00054749002573
510(k) Number
FDA product code
JJX
GMDN term
Human chorionic gonadotropin beta-core fragment IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Human chorionic gonadotropin beta-core fragment IVD, control

Cleared under the same submission (K121237)

Similar devices

Other devices filed under FDA product code JJX (Single (Specified) Analyte Controls (Assayed And Unassayed)).

Other devices from Abbott Point of Care Inc.

See all devices from Abbott Point of Care Inc. →

Properties

  • Single use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)