IRMA BLOOD ANALYSIS SYSTEM— 510(k) K945240
Substantially EquivalentDiametrics Medical, Inc.
FDA 510(k) clearance K945240 for IRMA BLOOD ANALYSIS SYSTEM, Substantially Equivalent on 1995-01-05. Applicant: Diametrics Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Diametrics Medical, Inc.
- Product code
- Code CHL
- Device class
- Class 2
- Regulation
- 21 CFR 862.1120
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Roseville, MN, US
Recent devices under product code CHL
view allMore clearances from Diametrics Medical, Inc.
view allAdverse events under product code CHL
product code CHL- Death
- 20
- Malfunction
- 999
- Total
- 1,019
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 K945240
K-number listed on FDA's recall record- Z-0159-2016 — CC cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 039903. The CC Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
- Z-0160-2016 — BG cartridges for IRMA TRUPOINT Blood Gas Analyzer, PN 048103. BG Cartridge are single use, disposable, in vitro diagnostics intended for point of care (POC), professional, use with the IRMA TRUpoint¿ Blood Analysis System.
- Z-1919-2015 — LifeHealth, IRMA TRUPOINT model 443914, typically used in point-of-care settings. For the in vitro measurement of various critical care analytes in human whole blood. These analytes includes: pO2, pCO2, pH, iCa, Na, K and Cl.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K945240.
Data sourced from openFDA. This site is unofficial and independent of the FDA.