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Diamedix 720-250

by Diamedix Corp.

Diamedix 720-250 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K970218 on 8 Apr 1997 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020082), 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) K970218

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 Number00817273020082 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970218 Date8 Apr 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970218 decided 8 Apr 1997 Active
  • FDA GUDID UDI-DI 00817273020082 listed 20 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K970218
  2. Listed FDA GUDID 00817273020082

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  • Withdrawn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
SSA/Ro antibody (Sjogren's antibody) IVD, reagent
Model / reference
720-250
Description
720-250 anti-SSA Test Kit
Primary DI / UDI-DI
00817273020082
510(k) Number
FDA product code
LLL
GMDN term
SSA/Ro antibody (Sjogren's antibody) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: SSA/Ro antibody (Sjogren's antibody) IVD, reagent

Cleared under the same submission (K970218)

Similar devices

Other devices filed under FDA product code LLL (Extractable Antinuclear Antibody, Antigen And Control).

Other devices from Diamedix Corp.

See all devices from Diamedix Corp. →

Properties

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