Liquichek 288

by Bio-Rad Laboratories

Liquichek 288 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K984071 on 3 Dec 1998 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 00847661004615), 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	Number00847661004615 UDI-DI	Date9 Jan 2017Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK984071	Date3 Dec 1998Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00847661004615
FDA 510(k) database 510(k) number K984071

Across registries

2 registries list this device

FDA 510(k) K984071 decided 3 Dec 1998 Active
FDA GUDID UDI-DI 00847661004615 listed 9 Jan 2017 Listed

Timeline

2 dated events

3 Dec 1998 Cleared FDA 510(k) K984071
9 Jan 2017 Listed FDA GUDID 00847661004615

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: Liquichek
Generic name: Homocysteine IVD, control
Model / Ref / Catalog: 288

Primary DI / UDI-DI: 00847661004615
510(k) Number: K984071
FDA product code: JJX
GMDN term: Homocysteine IVD, control

Device class: Class I
Regulation number: 862.1660
GUDID distribution status: In Commercial Distribution

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Properties

Single use
Lot / batch number
Expiration date

Other properties (12, all answered No)