THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS— 510(k) K041427

Clearance details

Applicant

Arkray, Inc.

Product code

Code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

2004-05-28

Decision date

2004-11-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Cortlandt Manor, NY, US

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Death

2

Malfunction

1,816

Total

1,818

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

• Z-0630-2016 — arkray SPOTCHEM II Glucose Reagent test strips, Item No. 77101, MEDTEST DX Catalog # 77424. For the in vitro quantitative determination of glucose in human plasma from whole blood samples.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 K041427.