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Trinity Biotech 2337470

by Clark Laboratories, Inc.

Trinity Biotech 2337470 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K935418 on 5 May 1994 and listed in FDA GUDID since 22 Sep 2016 (UDI-DI 05391516743785), 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) K935418

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 Number05391516743785 UDI-DI Date22 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK935418 Date5 May 1994DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K935418 decided 5 May 1994 Active
  • FDA GUDID UDI-DI 05391516743785 listed 22 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K935418
  2. Listed FDA GUDID 05391516743785

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Trinity Biotech
Generic name
Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
2337470
Primary DI / UDI-DI
05391516743785
510(k) Number
FDA product code
LLL
GMDN term
Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.5100
GUDID distribution status
In Commercial Distribution

Related devices

Category: Scleroderma-70 antibody (anti-Scl-70) IVD, kit, enzyme immunoassay (EIA)

Similar devices

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

Other devices from Clark Laboratories, Inc.

See all devices from Clark Laboratories, Inc. →

Properties

  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)