FDA.reportPublic FDA data

510(k) K011525

Device
SAFE AT HOME TSH (THYROID STIMULATING HORMONE BLOOD COLLECTION AND TRANSPORT SYSTEM)
Applicant
Biosafe Laboratories, Inc.
510(k) number
K011525
Product code
JLW
Decision
Substantially Equivalent (SESE)
Decision date
2001-07-16
Date received
2001-05-17
Regulation
862.1690
Classification name
Radioimmunoassay, Thyroid-Stimulating Hormone
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
LAURIE A WATERS
Address
100 Field Dr. #240 Lake Forest IL US 60045 60045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code JLW#

510(k), Device, Applicant table
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K222116Atellica® CI Analyzer, Atellica® IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica® CH Albumin BCP (AlbP)Siemens Healthcare Diagnostics, Inc.2023-07-13
K221225Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay AnalyzerBeckman Coulter, Inc.2022-11-10
K190773Elecsys TSHRoche Diagnostics2019-04-16
K170232AFIAS TSH-SP, AFIAS TSH-VB, AFIAS-6/SP Analyzer, AFIAS-6/VB AnalyzerBoditech Med, Inc.2017-10-13
K171103Lumipulse G TSH-III Immunoreaction CartridgesFujirebio Diagnostics,Inc.2017-07-28
K162698MAGLUMI 2000 TSH, MAGLUMI 2000 Immunoassay AnalyzerShenzhen New Industries Biomedical Engineering Co., Ltd.2017-07-14
K162606Elecsys TSH assay, cobas e 801 Immunoassay analyzerRoche Diagnostics2017-01-23
K160541Automated Immunoassay System HISCL -800, HISCL TSH Assay Kit, HISCL TSH Calibrator, HISCL Immuno Multi ControlSysmex America, Inc.2016-10-21
K153651Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay SystemsBeckman Coulter, Inc.2016-08-18
K160647IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4Siemens Healthcare Diagnostics, Inc.2016-05-31
K151792Trinidad IM Thyroid Stimulating Hormone (TSH) Assay, Trinidad IM TSH Calibrators, Trinidad Immunoassay (IM) SystemSiemens Healthcare Diagnostics, Inc.2015-11-20