CRIT-SCAN II MONITOR— 510(k) K983551
Substantially EquivalentIn-Line Diagnostics Corp.
FDA 510(k) clearance K983551 for CRIT-SCAN II MONITOR, Substantially Equivalent on 1999-05-27. Applicant: In-Line Diagnostics Corp.. Device class: 2.
Clearance details
- Applicant
- In-Line Diagnostics 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
- Farmington, UT, US
Recent devices under product code GKF
view all- K160415 — GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
- K981425 — STAT PROFILE ULTRA A, B, C, D, AND E ANALYZERS
- K981426 — STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
- K981427 — STAT PROFILE M ANALYZER
- K953519 — MICROSPIN 24
More clearances from In-Line Diagnostics Corp.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.