SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS— 510(k) K053401

Name: FDA 510(k) clearance K053401
Creator: U.S. Food and Drug Administration
Published: 2006-03-24

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K053401 for SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS, Substantially Equivalent on 2006-03-24. Applicant: Arkray, Inc.. Device class: 2.

Clearance details

Applicant: Arkray, Inc.
Product code: Code CIC
Device class: Class 2
Regulation: 21 CFR 862.1145
Advisory panel: Clinical Chemistry
Date received: 2005-12-06
Decision date: 2006-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K053401

K-number listed on FDA's recall record

Z-0631-2016 — arkray SPOTCHEM II Basic Panel - 1 Reagent test strips, Product # 11726, MEDTEST DX Catalog # 77484. Calcium, Blood Urea Nitrogen, Glucose, Albumin, Creatinine. For the in vitro quantitative determination of calcium, blood urea nitrogen (BUN), glucose, albumin, and creatinine.Class I·Terminated·Arkray Factory USA, Inc.·20151218

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053401.

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