Skip to content

Liquichek 115

by Bio-Rad Laboratories

Liquichek 115 is a Class II device made by Bio-Rad Laboratories, cleared under FDA 510(k) K024219 on 15 Jan 2003 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00847661000150), 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) K024219

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 Number00847661000150 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK024219 Date15 Jan 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K024219 decided 15 Jan 2003 Active
  • FDA GUDID UDI-DI 00847661000150 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K024219
  2. Listed FDA GUDID 00847661000150

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  • Withdrawn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
Sm/RNP antibody IVD, control
Model / Ref / Catalog
115
Primary DI / UDI-DI
00847661000150
510(k) Number
FDA product code
LKP
GMDN term
Sm/RNP antibody IVD, control
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Sm/RNP antibody IVD, control

Similar devices

Other devices filed under FDA product code LKP (ANTI-SM ANTIBODY, ANTIGEN AND 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)