TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113— 510(k) K012518

Name: FDA 510(k) clearance K012518
Creator: U.S. Food and Drug Administration
Published: 2001-10-09

Substantially Equivalent

Thermo Dma, Inc.

FDA 510(k) clearance K012518 for TRACE SCIENTIFIC ALKALINE PHOSPHATASE, TWO PART LIQUID, MODEL TR-113, Substantially Equivalent on 2001-10-09. Applicant: Thermo Dma, Inc.. Device class: 2.

Clearance details

Applicant: Thermo Dma, Inc.
Product code: Code CJE
Device class: Class 2
Regulation: 21 CFR 862.1050
Advisory panel: Clinical Chemistry
Date received: 2001-08-06
Decision date: 2001-10-09
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arlington, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJE

view all

K251074 — Tru Liver Health Test Panel2025-12-19
K240468 — Alkaline Phosphatase2024-10-16
K223317 — Alkaline Phosphatase22023-07-21
K191245 — Yumizen C1200 ALP, Yumizen C1200 Albumin2019-08-30
K171971 — Comprehensive Metabolic Panel, skyla Clinical Chemistry Analyzer, Minicare C300 Clinical Chemistry Analyzer2018-01-25

More clearances from Thermo Dma, Inc.

view all

K022108 — THERMO DMA DATA-CAL CALIBRATOR, MODEL 1905-0502002-07-25
K012878 — THERMO TRACE AMMONIA STANDARDS SET, MODELS TR-6092001-10-16
K012525 — THERMO DMA FRUCTOSAMINE ASSAY, MODEL 7500-135/2352001-10-04

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