Skip to content

Diamedix 720-630

by Diamedix Corp.

Diamedix 720-630 is a Class I device made by Diamedix Corp., cleared under FDA 510(k) K982352 on 25 Nov 1998 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020341), active as of 22 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 22 Oct 2026

Documents

510(k) K982352

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 Number00817273020341 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK982352 Date25 Nov 1998DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K982352 decided 25 Nov 1998 Active
  • FDA GUDID UDI-DI 00817273020341 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K982352
  2. Listed FDA GUDID 00817273020341

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  • Withdrawn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
Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / reference
720-630
Description
"720-630 EBNA-1 IgM Test Kit"
Primary DI / UDI-DI
00817273020341
510(k) Number
FDA product code
LSE
GMDN term
Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class I
Regulation number
866.3235
GUDID distribution status
In Commercial Distribution

Related devices

Category: Candida albicans immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K982352)

Similar devices

Other devices filed under FDA product code LSE (Epstein-Barr Virus, Other).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →

Properties

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