QS90 SMOOTH E ARTERIAL BLOOD SAMPLER— 510(k) K896514
Substantially EquivalentRadiometer America, Inc.
FDA 510(k) clearance K896514 for QS90 SMOOTH E ARTERIAL BLOOD SAMPLER, Substantially Equivalent on 1990-01-23. Applicant: Radiometer America, Inc.. Device class: 2.
Clearance details
- Applicant
- Radiometer America, Inc.
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Westlake, OH, US
Recent devices under product code GIM
view all- K240455 — BD Vacutainer® Citrate Blood Collection Tubes
- K230493 — BD MiniDraw Capillary Blood Collection System with BD MiniDraw H&H Capillary Blood Collection Tube
- K213670 — BD Vacutainer K2EDTA Blood Collection Tubes, BD Vacutainer K3EDTA Blood Collection Tubes
- K162723 — TransFix/EDTA Vacuum Blood Collection Tubes
- K080552 — CYTO-CHEX BCT
More clearances from Radiometer America, Inc.
view all- K153712 — VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit
- K992859 — ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
- K991417 — ABL 735 ANALYZER
- K982928 — NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
- K980130 — ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Adverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.