FILTER SAMPLER BLOOD SERUM FILTER— 510(k) K771985
Substantially EquivalentClasrock
FDA 510(k) clearance K771985 for FILTER SAMPLER BLOOD SERUM FILTER, Substantially Equivalent on 1977-11-02. Applicant: Clasrock. Device class: 2.
Clearance details
- Applicant
- Clasrock
- 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
- Mchenry, IL, 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
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.