DeviceClearance

NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM— 510(k) K063821

Substantially Equivalent

Nova Biomedical Corp.

FDA 510(k) clearance K063821 for NOVA STATSTRIP GLUCOSE HOSPITAL METER SYSTEM, Substantially Equivalent on 2007-01-24. Applicant: Nova Biomedical Corp.. Device class: 2.

Clearance details

Applicant
Nova Biomedical Corp.
Product code
Code CGA
Device class
Class 2
Regulation
21 CFR 862.1345
Advisory panel
Clinical Chemistry
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Walham, MA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CGA

product code CGA
Death
2
Malfunction
1,816
Total
1,818

Source: openFDA MAUDE database, through . 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 K063821

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K063821.

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