STAT PROFILE M ANALYZER— 510(k) K981427
Substantially EquivalentNova Biomedical Corp.
FDA 510(k) clearance K981427 for STAT PROFILE M ANALYZER, Substantially Equivalent on 1998-05-12. Applicant: Nova Biomedical Corp.. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corp.
- Product code
- Code GKF
- Device class
- Class 2
- Regulation
- 21 CFR 864.5600
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code GKF
view all- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
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- K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
- K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
- K953519 — MICROSPIN 24
More clearances from Nova Biomedical Corp.
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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
Data sourced from openFDA. This site is unofficial and independent of the FDA.