Skip to content

Diamedix 720-320

by Diamedix Corp.

Diamedix 720-320 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K981163 on 21 Sep 1998 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020150), active as of 22 Oct 2026. One FDA recall is linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

510(k) K981163

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817273020150 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK981163 Date21 Sep 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K981163 decided 21 Sep 1998 Active
  • FDA GUDID UDI-DI 00817273020150 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1689-2016 FDA Class II initiated 26 Mar 2015

    Product contained an incorrect substrate.

Timeline

3 dated events

  1. Cleared FDA 510(k) K981163
  2. Recall initiated FDA recalls Z-1689-2016
  3. Listed FDA GUDID 00817273020150

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Diamedix
Generic name
Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
Model / reference
720-320
Description
"720-320 CMV IgG Test Kit"
Primary DI / UDI-DI
00817273020150
510(k) Number
FDA product code
LFZ
GMDN term
Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)
Device class
Class II
Regulation number
866.3175
GUDID distribution status
In Commercial Distribution

Related devices

Category: Measles virus immunoglobulin G (IgG) antibody IVD, kit, complement fixation test (CFT)

Cleared under the same submission (K981163)

Similar devices

Other devices filed under FDA product code LFZ (Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →

Properties

  • Convenience kit
  • Lot / batch number
Other properties (13, all answered No)