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Liquichek 12004810

by Bio-Rad Laboratories

Liquichek 12004810 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K050537 on 27 Apr 2005 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 03610520865255), active as of 22 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 22 Oct 2026

Documents

510(k) K050537

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 Number03610520865255 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050537 Date27 Apr 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050537 decided 27 Apr 2005 Active
  • FDA GUDID UDI-DI 03610520865255 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050537
  2. Listed FDA GUDID 03610520865255

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  • Withdrawn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
Multiple cardiac marker IVD, control
Model / Ref / Catalog
12004810
Primary DI / UDI-DI
03610520865255
510(k) Number
FDA product code
JJY
GMDN term
Multiple cardiac marker IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple cardiac marker IVD, control

Cleared under the same submission (K050537)

and 8 more cleared under K050537

Similar devices in this category

Other devices filed under Multiple cardiac marker 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)