Cleared Traditional

ECLIPSE ICA TSH

K910256 · Biotope, Inc. · Chemistry
Feb 1991
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K910256 is an FDA 510(k) clearance for the ECLIPSE ICA TSH, a Radioimmunoassay, Thyroid-stimulating Hormone (Class II — Special Controls, product code JLW), submitted by Biotope, Inc. (Redmond, US). The FDA issued a Cleared decision on February 22, 1991, 31 days after receiving the submission on January 22, 1991. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1690.

Submission Details

510(k) Number K910256 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1991
Decision Date February 22, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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