Frend TSH (Reagent Cartridge)

FDA 510(k) K131928 · Nanoentek USA, Inc.

Substantially Equivalent

510(k) numberK131928

Submission

Device name
Frend TSH (Reagent Cartridge)
Applicant
Nanoentek USA, Inc.
Oxford, CT, US
Received
June 27, 2013
Decision date
March 14, 2014
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JLW – Radioimmunoassay, Thyroid-Stimulating Hormone
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1690
Specialty
Clinical Chemistry

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K234091Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0JLW · Traditional Genalyte, Inc.07/22/2024SE
K233050ADVIA Centaur® TSH3-Ultra II (TSH3ULII)JLW · Traditional Siemens Healthcare Diagnostics, Inc.04/04/2024SE
K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL)…JLW · Traditional Siemens Healthcare Diagnostics, Inc.07/13/2023SE
K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerJLW · Traditional Beckman Coulter, Inc.11/10/2022SE
K190773Elecsys TSHJLW · Traditional Roche Diagnostics04/16/2019SE
K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerJLW · Traditional Boditech Med, Inc.10/13/2017SE
K171103Lumipulse G TSH-III Immunoreaction CartridgesJLW · Traditional Fujirebio Diagnostics,Inc.07/28/2017SE
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerJLW · Traditional Shenzhen New Industries Biomedical Engineering…07/14/2017SE

More from Shenzhen New Industries Biomedical Engineering Co., Ltd.

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K162378FREND PSA PLUS (reagent cartridge)LTJ · Traditional 05/17/2017SE
K162754FREND Vitamin D Test SystemMRG · Traditional 01/12/2017SE
K153577FREND Testosterone Test SystemCDZ · Traditional 10/14/2016SE
K152422FREND™ Free T4 Test SystemCEC · Traditional 02/17/2016SE

Questions and answers

When was Frend TSH (Reagent Cartridge) cleared by the FDA?

Frend TSH (Reagent Cartridge) (K131928) received a 510(k) decision of Substantially Equivalent on March 14, 2014, 260 days after the submission was received.

What is the product code of K131928?

The FDA product code is JLW – Radioimmunoassay, Thyroid-Stimulating Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1690.