OPUS TOTAL CK

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

510(k) Number

K933675 ↗

FDA Product Code

CGS

Device Class

Class II

Regulation

21 CFR Part 862.1215

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 TOTAL CK device used for?

  The OPUS TOTAL CK is a clinical chemistry device designed for the measurement of Nad reduction/NADH oxidation, Cpk or isoenzymes in clinical chemistry laboratory settings.

• How is the OPUS TOTAL CK device supplied?

  The OPUS TOTAL CK is supplied by Pb Diagnostic Systems, Inc., with manufacturing located in Westwood, MA. It is classified as a Class 2 device under regulation 862.1215.

• What is the regulatory status of the OPUS TOTAL CK?

  The OPUS TOTAL CK received FDA 510(k) clearance on September 8, 1993, with clearance number K933675. It is a traditional clearance reviewed by the Clinical Chemistry advisory committee.

• Is the OPUS TOTAL CK device reusable or single-use?

  The device data does not specify whether the OPUS TOTAL CK is reusable or single-use. This information would need to be obtained directly from the manufacturer or product documentation.