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Liquichek 640X

by Bio-Rad Laboratories

Liquichek 640X is a multiple lipid analyte IVD (FDA Class I; FDA product code JJY, Multi-analyte controls, all kinds (assayed)) made by Bio-Rad Laboratories, cleared under FDA 510(k) K012513 on 29 Aug 2001 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661002109), 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) K012513

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 Number00847661002109 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK012513 Date29 Aug 2001DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K012513 decided 29 Aug 2001 Active
  • FDA GUDID UDI-DI 00847661002109 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K012513
  2. Listed FDA GUDID 00847661002109

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  • Withdrawn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 lipid analyte IVD, control
Model / Ref / Catalog
640X
Primary DI / UDI-DI
00847661002109
510(k) Number
FDA product code
JJY
GMDN term
Multiple lipid analyte IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple lipid analyte IVD, control

Cleared under the same submission (K012513)

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)