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Lyphochek 528X

by Bio-Rad Laboratories

Lyphochek 528X is a multiple heavy metal IVD (FDA Class I; FDA product code DIE, Heavy Metals Control Materials) made by Bio-Rad Laboratories, cleared under FDA 510(k) K020610 on 22 Apr 2002 and listed in FDA GUDID since 9 Jan 2017 (UDI-DI 00847661001843), 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) K020610

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 Number00847661001843 UDI-DI Date9 Jan 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK020610 Date22 Apr 2002DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K020610 decided 22 Apr 2002 Active
  • FDA GUDID UDI-DI 00847661001843 listed 9 Jan 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K020610
  2. Listed FDA GUDID 00847661001843

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Lyphochek
Generic name
Multiple heavy metal IVD, control
Model / Ref / Catalog
528X
Primary DI / UDI-DI
00847661001843
510(k) Number
FDA product code
DIE
GMDN term
Multiple heavy metal IVD, control
Device class
Class I
Regulation number
862.3280
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple heavy metal IVD, control

Cleared under the same submission (K020610)

Similar devices

Other devices filed under FDA product code DIE (HEAVY METALS CONTROL MATERIALS).

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)