SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS— 510(k) K051648

Name: FDA 510(k) clearance K051648
Creator: U.S. Food and Drug Administration
Published: 2006-01-31

Substantially Equivalent

Arkray, Inc.

FDA 510(k) clearance K051648 for SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS, Substantially Equivalent on 2006-01-31. Applicant: Arkray, Inc.. Device class: 2.

Clearance details

Applicant: Arkray, Inc.
Product code: Code CGS
Device class: Class 2
Regulation: 21 CFR 862.1215
Advisory panel: Clinical Chemistry
Date received: 2005-06-21
Decision date: 2006-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cortlandt Manor, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGS

view all

K191296 — Pointe Scientific Creatinine Kinase (CK) Reagent Set2020-08-11
K182702 — SEKURE Creatine Kinase Assay2019-04-17
K160724 — ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator2016-09-07
K123977 — RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR2013-11-21
K112416 — CPK REAGENT2011-11-09

More clearances from Arkray, Inc.

view all

K232416 — AUTION EYE AI-4510 Urine Particle Analysis System2024-05-03
K193514 — AUTION MAX AX-4060 Urinalysis System2023-04-13
K221175 — Multi-Lancet Device 2, ReliOn Premier Lancing Device2022-10-17
K200788 — Assure Titanium Blood Glucose Monitoring System2022-05-23
K160062 — AUTION ELEVEN Semi-Automated Urinalysis System2016-10-07

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