Skip to content

Trinity Biotech Enzyme Cleaner Tube

by Primus Corp.

Trinity Biotech Enzyme Cleaner Tube (01-12-0001) is a Class II device made by Primus Corp., cleared under FDA 510(k) K891235 on 16 Jun 1989 and listed in FDA GUDID since 6 Sep 2016 (UDI-DI 05391516744546), 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) K891235

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 Number05391516744546 UDI-DI Date6 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK891235 Date16 Jun 1989DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K891235 decided 16 Jun 1989 Active
  • FDA GUDID UDI-DI 05391516744546 listed 6 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K891235
  2. Listed FDA GUDID 05391516744546

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  • Withdrawn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
Medical device-decontamination agent
Model / Ref / Catalog
Enzyme Cleaner Tube, 01-12-0001
Primary DI / UDI-DI
05391516744546
510(k) Number
FDA product code
LCP
GMDN term
Medical device-decontamination agent
Device class
Class II
Regulation number
864.7470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Medical device-decontamination agent

Cleared under the same submission (K891235)

and 8 more cleared under K891235

Similar devices

Other devices filed under FDA product code LCP (Assay, Glycosylated Hemoglobin).

Other devices from Primus Corp.

See all devices from Primus Corp. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (10, all answered No)