GLUCOSE REAGENT SET (GOD/TRINDER)— 510(k) K854335

Clearance details

Applicant

Sterling Diagnostics, Inc.

Product code

Product code CGA

Device class

Class 2

Regulation

21 CFR 862.1345

Advisory panel

Clinical Chemistry

Date received

1985-10-28

Decision date

1985-11-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Sterling Heights, MI, 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-0932-2017 — Sterling Diagnostics, Inc., Enzymatic Glucose for IN VITRO DIAGNOSTIC USE in the quantitative determination of analytes. These are CONSUMABLES - a customer buys another when kit is consumed.Class III·Terminated·Sterling Diagnostics, Inc.·20160720

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K854335.