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Trinity Biotech 2325160

by Clark Laboratories, Inc.

Trinity Biotech 2325160 is a Class II device made by Clark Laboratories, Inc., cleared under FDA 510(k) K920702 on 8 Jul 1992 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 05391516743396), 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) K920702

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 Number05391516743396 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK920702 Date8 Jul 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K920702 decided 8 Jul 1992 Active
  • FDA GUDID UDI-DI 05391516743396 listed 21 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K920702
  2. Listed FDA GUDID 05391516743396

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  • Withdrawn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
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Model / Ref / Catalog
2325160
Primary DI / UDI-DI
05391516743396
510(k) Number
FDA product code
LGD
GMDN term
Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)
Device class
Class II
Regulation number
866.3780
GUDID distribution status
In Commercial Distribution

Related devices

Category: Toxoplasma gondii immunoglobulin M (IgM) antibody IVD, kit, enzyme immunoassay (EIA)

Cleared under the same submission (K920702)

Similar devices

Other devices filed under FDA product code LGD (Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii).

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)