Reprobead TSH Enzyme Immunoassay Reagent Kit (Catalog# 107)

FDA 510(k) K001606 · Repromedix Corp.

Substantially Equivalent

510(k) numberK001606

Submission

Device name
Reprobead TSH Enzyme Immunoassay Reagent Kit (Catalog# 107)
Applicant
Repromedix Corp.
Woburn, MA, US
Received
May 24, 2000
Decision date
October 5, 2000
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement 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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K243570Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI…JLW · Traditional Siemens Healthcare Diagnostics04/25/2025SE
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.

510(k)DeviceDecision
K001607Reprobead T3 Enzyme Immunoassay Reagent Kit (Catalog# 104)CDP · Traditional 10/05/2000SE
K001603Reprobead T4 Enzyme Immunoassay Reagent Kit (Catalog# 105)KLI · Traditional 10/05/2000SE

Questions and answers

When was Reprobead TSH Enzyme Immunoassay Reagent Kit (Catalog# 107) cleared by the FDA?

Reprobead TSH Enzyme Immunoassay Reagent Kit (Catalog# 107) (K001606) received a 510(k) decision of Substantially Equivalent on October 5, 2000, 134 days after the submission was received.

What is the product code of K001606?

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