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Ready Sensor™ Lactate Biosensor 10316526

by Siemens Healthcare Diagnostics Inc.

Ready Sensor™ Lactate Biosensor 10316526 (2144067) is a Class II device made by Siemens Healthcare Diagnostics Inc., cleared under FDA 510(k) K934907 on 3 Jan 1994 and listed in FDA GUDID since 24 Sep 2016 (UDI-DI 00630414468143), 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) K934907

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 Number00630414468143 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK934907 Date3 Jan 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K934907 decided 3 Jan 1994 Active
  • FDA GUDID UDI-DI 00630414468143 listed 24 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K934907
  2. Listed FDA GUDID 00630414468143

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Ready Sensor™ Lactate Biosensor
Generic name
Lactate electrode IVD
Model / Ref / Catalog
10316526, 2144067
Primary DI / UDI-DI
00630414468143
510(k) Number
FDA product code
CHL
GMDN term
Lactate electrode IVD
Device class
Class II
Regulation number
862.1120
GUDID distribution status
In Commercial Distribution

Related devices

Category: Lactate electrode IVD

Cleared under the same submission (K934907)

and 6 more cleared under K934907

Similar devices

Other devices filed under FDA product code CHL (ELECTRODE MEASUREMENT, BLOOD-GASES (PCO2, PO2) AND BLOOD PH).

Other devices from Siemens Healthcare Diagnostics Inc.

See all devices from Siemens Healthcare Diagnostics Inc. →

Properties

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