ABL8X7 FLEX— 510(k) K051968
Substantially EquivalentRadiometer Medical Aps
FDA 510(k) clearance K051968 for ABL8X7 FLEX, Substantially Equivalent on 2006-10-16. Applicant: Radiometer Medical Aps. Device class: 2.
Clearance details
- Applicant
- Radiometer Medical Aps
- 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
- Bronshoj, DK
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More clearances from Radiometer Medical Aps
view allRecalls naming K051968
K-number listed on FDA's recall record- Z-0801-2019 — Product: ABL800 FLEX with Crea. The ABL800 with Crea is available in the following configurations: ABL817, ABL827 and ABL837. ABL800 Series Ref. 393-803, 393-804, 393-805, 393-806, 393-820, 393-821, 393-825, 393-826, 393-835, 393-836, 393-844, 393-845.
- Z-1293-2015 — Crea A and B membranes, packaged 4 per box Used in conjunction with the ABL800 FLEX analyzers which are intended for: In Vitro Testing of samples of whole blood for the parameters pCO2, cK+,cNa+, cCa2+,cCl-,cGlu, cLac, cCrea, ctBil, and co-oximetry parameters,(ctHb, sO2, and the hemoglobin fractions FO2Hb, FCOHb, FMetHb, FHHb and FHbF), in vitro testing of samples of expired air for the parameters pO2 and pCO2, in vitro testing of pleura samples for the pH parameter.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051968.
Data sourced from openFDA. This site is unofficial and independent of the FDA.