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Liquichek 646

by Bio-Rad Laboratories

Liquichek 646 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K040277 on 10 Mar 2004 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 00847661000679), 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) K040277

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 Number00847661000679 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK040277 Date10 Mar 2004DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K040277 decided 10 Mar 2004 Active
  • FDA GUDID UDI-DI 00847661000679 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K040277
  2. Listed FDA GUDID 00847661000679

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  • Withdrawn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 cardiac marker IVD, control
Model / Ref / Catalog
646
Primary DI / UDI-DI
00847661000679
510(k) Number
FDA product code
JJY
GMDN term
Multiple cardiac marker IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple cardiac marker IVD, control

Cleared under the same submission (K040277)

and 2 more cleared under K040277

Similar devices in this category

Other devices filed under Multiple cardiac marker 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)