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Meter Trax 971

by Bio-Rad Laboratories

Meter Trax 971 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K042336 on 14 Oct 2004 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661003199), 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) K042336

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 Number00847661003199 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK042336 Date14 Oct 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K042336 decided 14 Oct 2004 Active
  • FDA GUDID UDI-DI 00847661003199 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K042336
  2. Listed FDA GUDID 00847661003199

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Meter Trax
Generic name
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Model / Ref / Catalog
971
Primary DI / UDI-DI
00847661003199
510(k) Number
FDA product code
JJY, JPK
GMDN term
Multiple blood gas/haemoximetry/electrolyte analyte IVD, control
Device class
Class I
Regulation number
862.1660, 864.8625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple blood gas/haemoximetry/electrolyte analyte IVD, control

Cleared under the same submission (K042336)

Similar devices in this category

Other devices filed under Multiple blood gas/haemoximetry/electrolyte analyte IVD, control.

Other devices from Bio-Rad Laboratories

See all devices from Bio-Rad Laboratories →

Properties

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