Amerlex-M T4 RIA Kit for Serum and Plasma

No FDA recalls on record, checked 6 Oct 2026.

510(k) Number

K860251 ↗

FDA Product Code

CEC

Device Class

Class II

Regulation

21 CFR Part 862.1695

Advisory Committee

Clinical Chemistry

FDA Decision

SESE Substantially Equivalent

• Amerlite Tsh Assay, LAN.0001/2001 240 & 144 Kit

  Class II

  FDA 510(k) K882907 Active Cleared 22 Sep 1988

• Amerlite Lh-30 Assay, LAN.0082/2082 240/144 Test

  Class I

  FDA 510(k) K880933 Active Cleared 28 Jul 1988

• Amerlite Fsh Assay, LAN.0077/2077 240 and 144 Test

  Class I

  FDA 510(k) K881142 Active Cleared 21 Jul 1988

• Amerlite Reproductive Endocrinology (Label Change)

  Class I

  FDA 510(k) K890708 Active Cleared 20 Mar 1989

• Prolactin Ria Kit

  Class I

  FDA 510(k) K800740 Active Cleared 16 Apr 1980

• Gold(Au 195) Gamma Camera Check(Flood)

  Class II

  FDA 510(k) K812236 Active Cleared 9 Sep 1981

See all devices from Amersham Corp. →

• What is the AMERLEX-M T4 RIA Kit used for?

  The AMERLEX-M T4 RIA Kit is a radioimmunoassay designed to measure free thyroxine (T4) levels in human serum and plasma specimens. It is intended for in vitro diagnostic use within the Clinical Chemistry specialty to assess thyroid function by quantifying T4 hormone concentration.

• How is the AMERLEX-M T4 RIA Kit supplied and what are its components?

  The kit is supplied as a complete radioimmunoassay system for free T4 measurement, including all necessary reagents such as labeled tracer, antibody, standards, and controls required to perform the assay. It is manufactured by Amersham Corp. and intended for use in clinical laboratory settings following the provided protocol.

• Is the AMERLEX-M T4 RIA Kit sterile or single-use?

  The device data does not specify sterility or single-use status for the AMERLEX-M T4 RIA Kit. As a radioimmunoassay kit, it contains reagents and biological components that are typically handled as per standard laboratory practices for in vitro diagnostics, but users should consult the manufacturer’s labeling for specific handling, storage, and use instructions.

• What regulatory pathway was used for the AMERLEX-M T4 RIA Kit?

  The AMERLEX-M T4 RIA Kit received FDA 510(k) clearance under submission number K860251 on February 11, 1986. It was determined to be substantially equivalent to a legally marketed predicate device, which is the regulatory pathway for moderate-risk Class II medical devices in the United States.