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Liquichek 545X

by Bio-Rad Laboratories

Liquichek 545X is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K955024 on 28 Nov 1995 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661001850), 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) K955024

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 Number00847661001850 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK955024 Date28 Nov 1995DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K955024 decided 28 Nov 1995 Active
  • FDA GUDID UDI-DI 00847661001850 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K955024
  2. Listed FDA GUDID 00847661001850

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Liquichek
Generic name
Ammonia IVD, control
Model / Ref / Catalog
545X
Primary DI / UDI-DI
00847661001850
510(k) Number
FDA product code
JJY
GMDN term
Ammonia IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Ethanol (ETOH) IVD, controlAmmonia IVD, control

Cleared under the same submission (K955024)

Similar devices

Other devices filed under FDA product code JJY (Multi-analyte controls, all kinds (assayed)).

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)