NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS— 510(k) K060345
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K060345 for NOVA STATSTRIP GLUCOSE HOSPITAL METER, STATSTRIP CONTROL SOLUTIONS, Substantially Equivalent on 2006-04-28. 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
Recent devices under product code CGA
view allMore clearances from Nova Biomedical Corp.
view all- K100602 — NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
- K101633 — NOVA MAX PLUS GLOCOSE AND B-KETONE CONTROL SOLUTION-MID, HIGH
- K091547 — NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS
- K070960 — NOVA STATSTRIP XPRESS GLUCOSE HOSPITAL METER SYSTEM
- K070255 — NOVA MAX BLOOD GLUCOSE MONITOR SYSTEM, 90001,90002
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 K060345
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060345.
Data sourced from openFDA. This site is unofficial and independent of the FDA.