CYTO-CHEX BCT— 510(k) K080552
Substantially EquivalentStreck
FDA 510(k) clearance K080552 for CYTO-CHEX BCT, Substantially Equivalent on 2008-07-31. Applicant: Streck. Device class: 2.
Clearance details
- Applicant
- Streck
- 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
- La Vista, NE, 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
- K012152 — DS30 HCY BLOOD COLLECTION TUBES
More clearances from Streck
view allAdverse 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 →
Recalls naming K080552
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K080552.
Data sourced from openFDA. This site is unofficial and independent of the FDA.