Cleared Special

VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM

K083173 · Ortho-Clinical Diagnostics · Chemistry
Dec 2008
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K083173 is an FDA 510(k) clearance for the VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Ortho-Clinical Diagnostics (Rochester, US). The FDA issued a Cleared decision on December 22, 2008, 56 days after receiving the submission on October 27, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K083173 FDA.gov
FDA Decision Cleared SESE
Date Received October 27, 2008
Decision Date December 22, 2008
Days to Decision 56 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JLW — Radioimmunoassay, Thyroid-stimulating Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1690

Similar Devices — JLW Radioimmunoassay, Thyroid-stimulating Hormone

All 241
Atellica? IM TSH3-Ultra II (TSH3ULII)
K251543 · Siemens Healthcare Diagnostics, Inc. · Feb 2026
Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL); Dimension LOCI Free Thyroxine Flex reagent cartridge (FT4L)
K243570 · Siemens Healthcare Diagnostics · Apr 2025
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
K234091 · Genalyte, Inc. · Jul 2024
ADVIA Centaur? TSH3-Ultra II (TSH3ULII)
K233050 · Siemens Healthcare Diagnostics, Inc. · Apr 2024
Atellica? CI Analyzer, Atellica? IMThyroid Stimulating Hormone 3-Ultra (TSH3-UL), Atellica? CH Albumin BCP (AlbP)
K222116 · Siemens Healthcare Diagnostics, Inc. · Jul 2023
Access TSH (3rd IS) Assay, DxI 9000 Access Immunoassay Analyzer
K221225 · Beckman Coulter, Inc. · Nov 2022