Bilirubin(Total) QVET

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

510(k) Number

K942999 ↗

FDA Product Code

CIG

Device Class

Class II

Regulation

21 CFR Part 862.1110

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Uric Acid Qvet

  Class I

  FDA 510(k) K943002 Active Cleared 2 Dec 1994

• Bilirubin (Direct) Qvet

  Class II

  FDA 510(k) K942949 Active Cleared 22 Nov 1994

• Ck Qvet

  Class II

  FDA 510(k) K950177 Active Cleared 3 Mar 1995

• Total Protein Qvet

  Class II

  FDA 510(k) K943004 Active Cleared 9 Dec 1994

• Creatinine Qvet

  Class II

  FDA 510(k) K943005 Active Cleared 22 Nov 1994

• Ggt Qvet

  Class I

  FDA 510(k) K942962 Active Cleared 7 Dec 1994

See all devices from Prisma Systems →

• What is the Bilirubin(Total) QVET test system used for?

  The Bilirubin(Total) QVET test system is intended to measure the levels of bilirubin (total or direct) in plasma or serum. These measurements are used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, as stated in the device description.

• How is the Bilirubin(Total) QVET test system supplied and what is its regulatory status?

  The device is supplied by Prisma Systems and received FDA 510(k) clearance under K number K942999 with product code CIG. It is classified as a Class II device under regulation number 862.1110 for clinical chemistry applications, based on the authorization and specification data provided.

• What type of clearance did the Bilirubin(Total) QVET receive and when was it granted?

  The Bilirubin(Total) QVET received traditional FDA 510(k) clearance, as indicated by the clearance_type field. The decision date was December 2, 1994, following receipt of the submission on June 23, 1994, according to the dates in the device data.