Las-R Tm Human Complement C4 Test

No FDA recalls found in the data synced 6 Oct 2026.

510(k) Number

K770547 ↗

FDA Product Code

DAK

Device Class

Class II

Regulation

21 CFR Part 866.5240

Advisory Committee

Immunology

FDA Decision

SESE Substantially Equivalent

• Low Ionic Strength Solution (Liss)

  Class II

  FDA 510(k) K791113 Active Cleared 28 Jun 1979

• Las-R Human Plasminogen Test

  Class I

  FDA 510(k) K772085 Active Cleared 24 Jan 1978

• Q-Pak Chemistry Radioreceptor Control C

  Class II

  FDA 510(k) K770012 Active Cleared 18 Apr 1977

• Tma Bicarbonate/Glycerol Diluent

  Not classified

  FDA 510(k) K771700 Active Cleared 11 Nov 1977

• Las-R Human Ige Test

  Class II

  FDA 510(k) K780753 Active Cleared 6 Jun 1978

• Las-R Test Program

  Class II

  FDA 510(k) K771226 Active Cleared 21 Jul 1977

See all devices from Hyland Therapeutic Div., Travenol Laboratories →

• What is the primary purpose of the LAS-R™ Human Complement C4 Test in a clinical setting?

  The LAS-R™ Human Complement C4 Test is designed specifically for detecting and measuring human complement C4 levels in laboratory settings. Complement C4 is a protein involved in the immune response, and its measurement can help assess immune function, diagnose autoimmune disorders, or monitor certain medical conditions related to immunology.

• Is this test system intended for single-use or repeated use in a laboratory?

  The LAS-R™ Human Complement C4 Test is supplied as a test system, which implies it is intended for single-use per test procedure. Components like antigens, antisera, and controls are typically designed for one-time use to ensure accuracy and prevent cross-contamination, though specific components may vary—always follow the manufacturer’s instructions for proper usage.

• How is the LAS-R™ Human Complement C4 Test regulated, and what does that mean for its use?

  The test received FDA 510(k) clearance under K770547, confirming it meets regulatory standards as a Class II medical device under product code DAK. This classification means it is subject to stricter controls than Class I devices but does not require premarket approval. Clinicians and labs can rely on its compliance with FDA requirements for immunology-related diagnostic tests.

• What types of laboratory settings is this test intended for, and what are its key components?

  The LAS-R™ Human Complement C4 Test is exclusively intended for use in laboratory settings, particularly those specializing in immunology. The test system includes complement C1q antigen, antiserum, and control materials, which work together to facilitate accurate detection and quantification of human complement C4 levels in patient samples.