ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM— 510(k) K120183

Name: FDA 510(k) clearance K120183
Creator: U.S. Food and Drug Administration
Published: 2012-05-11

Substantially Equivalent

Broadmaster Biotech Corperation

FDA 510(k) clearance K120183 for ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM, Substantially Equivalent on 2012-05-11. Applicant: Broadmaster Biotech Corperation. Device class: 2.

Clearance details

Applicant: Broadmaster Biotech Corperation
Product code: Code NBW
Device class: Class 2
Regulation: 21 CFR 862.1345
Advisory panel: Clinical Chemistry
Date received: 2012-01-23
Decision date: 2012-05-11
Decision: Substantially Equivalent
Clearance type: Special
Location: Zhonghe Dist, TW

Download summary PDF View on FDA.gov ↗

Recent devices under product code NBW

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Adverse events under product code NBW

product code NBW

Death: 18
Injury: 4,740
Malfunction: 42,679
Other: 6
Total: 47,443

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 →

Recalls naming K120183

K-number listed on FDA's recall record

Z-2021-2014 — ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE¿ Redi-Code+ BMB-BA006A Blood Glucose test strips are used only with the ADVOCATE¿ Redi-Code+ BMB-EA004S meter to quantitatively measure glucose in fresh capillary whole blood samples drawn from finger tips, the palm, the forearm, the upper arm, the calf, and the thigh.Class I·Terminated·DIABETIC SUPPLY OF SUNCOAST, INC.·20140505

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K120183.

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