VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS— 510(k) K994145

Name: FDA 510(k) clearance K994145
Creator: U.S. Food and Drug Administration
Published: 1999-12-22

Substantially Equivalent

Ortho-Clinical Diagnostics, Inc.

FDA 510(k) clearance K994145 for VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 REAGENT PACK, VITROS IMMUNODIAGNOSTIC PRODUCTS FREE T3 CALIBRATORS, Substantially Equivalent on 1999-12-22. Applicant: Ortho-Clinical Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Ortho-Clinical Diagnostics, Inc.
Product code: Code JIS
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 1999-12-08
Decision date: 1999-12-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Rochester, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K994145

K-number listed on FDA's recall record

Z-1818-2024 — VITROS Immunodiagnostic Products Free T3 Reagent Pack-IVD is for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 131 5589Class II·Ongoing·QUIDELORTHO·20240409
Z-1819-2024 — VITROS Immunodiagnostic Products Free T3 Calibrators-IVD are for use with Free T3 Reagent Pack for the quantitative measurement of free triiodothyronine (FT3) in human serum and plasma (EDTA or heparin). Product Code: 111 2820Class II·Ongoing·QUIDELORTHO·20240409

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K994145.

Data sourced from openFDA. This site is unofficial and independent of the FDA.