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Diamedix 720-240

by Diamedix Corp.

Diamedix 720-240 is a Class II device made by Diamedix Corp., cleared under FDA 510(k) K970220 on 8 Apr 1997 and listed in FDA GUDID since 20 Sep 2016 (UDI-DI 00817273020075), 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) K970220

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 Number00817273020075 UDI-DI Date20 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK970220 Date8 Apr 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K970220 decided 8 Apr 1997 Active
  • FDA GUDID UDI-DI 00817273020075 listed 20 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-0445-2013 FDA Class II initiated 6 Aug 2012

    Diamedix Corporation recalled their Is-anti-Sm Test Kit due to the Positive Control recovering high out of specification.

Timeline

3 dated events

  1. Cleared FDA 510(k) K970220
  2. Recall initiated FDA recalls Z-0445-2013
  3. Listed FDA GUDID 00817273020075

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  • Withdrawn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
Smith antibody (anti-Sm) IVD, reagent
Model / reference
720-240
Primary DI / UDI-DI
00817273020075
510(k) Number
FDA product code
LLL
GMDN term
Smith antibody (anti-Sm) IVD, reagent
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Smith antibody (anti-Sm) IVD, reagent

Cleared under the same submission (K970220)

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

  • Lot / batch number
Other properties (14, all answered No)