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Liquichek 927X

by Bio-Rad Laboratories

Liquichek 927X is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K100050 on 29 Jan 2010 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847661003878), 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) K100050

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 Number00847661003878 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK100050 Date29 Jan 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K100050 decided 29 Jan 2010 Active
  • FDA GUDID UDI-DI 00847661003878 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K100050
  2. Listed FDA GUDID 00847661003878

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  • Withdrawn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
Reticulocyte count IVD, control
Model / Ref / Catalog
927X
Primary DI / UDI-DI
00847661003878
510(k) Number
FDA product code
JPK
GMDN term
Reticulocyte count IVD, control
Device class
Class II
Regulation number
864.8625
GUDID distribution status
In Commercial Distribution

Related devices

Category: Reticulocyte count IVD, control

Cleared under the same submission (K100050)

Similar devices in this category

Other devices filed under Reticulocyte count 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)