NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS— 510(k) K070068
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K070068 for NOVA STATSENSOR CREATININE HOSPITAL METER, CONTROL SOLUTIONS,LINEARITY SOLUTIONS, AND TEST STRIPS, Substantially Equivalent on 2007-05-07. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code CGL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1225
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code CGL
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- 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
Recalls naming K070068
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 K070068.
Data sourced from openFDA. This site is unofficial and independent of the FDA.