Liquichek 922X

by Bio-Rad Laboratories

Liquichek 922X is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K010461 on 3 Apr 2001 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847661003830), 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

FDA submission, from GUDID

Trust

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00847661003830 UDI-DI	Date12 Sep 2016Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK010461	Date3 Apr 2001Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00847661003830
FDA 510(k) database 510(k) number K010461

Across registries

2 registries list this device

FDA 510(k) K010461 decided 3 Apr 2001 Active
FDA GUDID UDI-DI 00847661003830 listed 12 Sep 2016 Listed

Timeline

2 dated events

3 Apr 2001 Cleared FDA 510(k) K010461
12 Sep 2016 Listed FDA GUDID 00847661003830

Coverage

1 jurisdiction

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Withdrawn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: 922X

Primary DI / UDI-DI: 00847661003830
510(k) Number: K010461
FDA product code: JPK
GMDN term: Reticulocyte count IVD, control

Device class: Class II
Regulation number: 864.8625
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)