Opus T3 Test System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K905410 ↗

FDA Product Code

CDP

Device Class

Class II

Regulation

21 CFR Part 862.1710

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Opus Napa

  Class II

  FDA 510(k) K934705 Active Cleared 22 Nov 1993

• Opus Tsh Test System

  Class II

  FDA 510(k) K902333 Active Cleared 5 Jul 1990

• Opus Digitoxin

  Class II

  FDA 510(k) K935229 Active Cleared 22 Dec 1993

• Opus Immunoassay System

  Class I

  FDA 510(k) K894159 Active Cleared 3 Aug 1989

• Opus FT4 Test System

  Class II

  FDA 510(k) K940507 Active Cleared 28 Jul 1994

• Opus Phenobarbital Test System

  Class II

  FDA 510(k) K896861 Active Cleared 11 Jan 1990

See all devices from Pb Diagnostic Systems, Inc. →

• What is the OPUS T3 TEST SYSTEM used for?

  The OPUS T3 TEST SYSTEM is a clinical chemistry device designed for radioimmunoassay of total triiodothyronine (T3) in patient samples. It measures T3 levels for diagnostic purposes, helping clinicians assess thyroid function.

• Is the OPUS T3 TEST SYSTEM single-use or reusable?

  The OPUS T3 TEST SYSTEM is supplied as either a single-use or reusable device, though specific sterility information is not provided in the device data. Users should follow the manufacturer's instructions for proper handling and disposal.

• What regulatory approvals does the OPUS T3 TEST SYSTEM have?

  The OPUS T3 TEST SYSTEM received FDA 510(k) clearance with number K905410 on February 4, 1991, after a 63-day review process. It is classified as a Class 2 device with product code CDP for clinical chemistry applications.

• Can the OPUS T3 TEST SYSTEM be used in MRI environments?

  No, the OPUS T3 TEST SYSTEM is not indicated for MRI use. The device should only be used in its intended clinical chemistry testing environments as specified by the manufacturer.