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Lyphochek 278

by Bio-Rad Laboratories

Lyphochek 278 is a Class I device made by Bio-Rad Laboratories, cleared under FDA 510(k) K072721 on 11 Dec 2007 and listed in FDA GUDID since 14 Sep 2020 (UDI-DI 00847661003342), 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) K072721

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 Number00847661003342 UDI-DI Date14 Sep 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072721 Date11 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072721 decided 11 Dec 2007 Active
  • FDA GUDID UDI-DI 00847661003342 listed 14 Sep 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072721
  2. Listed FDA GUDID 00847661003342

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  • Withdrawn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 immunosuppressant therapeutic drug monitoring IVD, control
Model / Ref / Catalog
278
Primary DI / UDI-DI
00847661003342
510(k) Number
FDA product code
DIF
GMDN term
Multiple immunosuppressant therapeutic drug monitoring IVD, control
Device class
Class I
Regulation number
862.3280
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple immunosuppressant therapeutic drug monitoring IVD, control

Cleared under the same submission (K072721)

and 1 more cleared under K072721

Similar devices

Other devices filed under FDA product code DIF (Drug mixture 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)