Las-R Human Antithrombin III Test

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

510(k) Number

K772328 ↗

FDA Product Code

JBQ

Device Class

Class II

Regulation

21 CFR Part 864.7060

Advisory Committee

Hematology

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 Antithrombin III Test?

  The Las-R Human Antithrombin III Test is an in vitro diagnostic device designed for the laboratory quantitation of antithrombin III levels in human samples.

• What is the regulatory status of this diagnostic test?

  This device is classified under hematology and is regulated under FDA 510(k) clearance, which indicates that it has been found substantially equivalent to legally marketed predicate devices.

• Who is the intended user for this diagnostic device?

  The test is intended for professional laboratory use to assist clinicians in the assessment of antithrombin III protein levels within human samples.