Dac-Cel TSH

FDA 510(k) K810213 · Burroughs Wellcome Co.

Substantially Equivalent

510(k) numberK810213

Submission

Device name
Dac-Cel TSH
Applicant
Burroughs Wellcome Co.
Walker, MI, US
Received
January 27, 1981
Decision date
February 10, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

Other 510(k)s with product code JLW

510(k)DeviceApplicantDecision
K251543Atellica® IM TSH3-Ultra II (TSH3ULII)JLW · Traditional Siemens Healthcare Diagnostics, Inc.02/06/2026SE
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
K820069Wellcogen Group BGTZ · Traditional 02/18/1982SE
K813508Sac-CelKTS · Traditional 12/29/1981SE
K810215Dac-Cel HCGJHI · Traditional 04/17/1981SE
K810214Dac-Cel DiagnatalJHI · Traditional 03/06/1981SE
K810212Dac-Cel T3 UptakeKHQ · Traditional 02/10/1981SE
K791232Dac-Cel T3CDP · Traditional 09/04/1979SE
K791231Dac-Cel T4CDX · Traditional 09/04/1979SE
K781607Strep-TexGTZ · Traditional 10/17/1978SE
K780874Thymune-TDDC · Traditional 06/14/1978SE
K780873Thymune-MDDC · Traditional 06/14/1978SE

Questions and answers

When was Dac-Cel TSH cleared by the FDA?

Dac-Cel TSH (K810213) received a 510(k) decision of Substantially Equivalent on February 10, 1981, 14 days after the submission was received.

What is the product code of K810213?

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