TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS— 510(k) K970836
Substantially EquivalentBecton Dickinson Immunocytometry Systems
FDA 510(k) clearance K970836 for TRUCOUNT ABSOLUTE COUNT TUBES/COUNTING CONTROL BEADS, Substantially Equivalent on 1997-08-26. Applicant: Becton Dickinson Immunocytometry Systems. Device class: 2.
Clearance details
- Applicant
- Becton Dickinson Immunocytometry Systems
- Product code
- Code GKZ
- Device class
- Class 2
- Regulation
- 21 CFR 864.5220
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- San Jose, CA, US
Recent devices under product code GKZ
view allMore clearances from Becton Dickinson Immunocytometry Systems
view allAdverse events under product code GKZ
product code GKZ- Malfunction
- 1,205
- Total
- 1,205
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 K970836
K-number listed on FDA's recall record- Z-2252-2016 — BD Trucount Tubes: Catalog number: 340334 Hematology: BD Trucount tubes are used for determining absolute counts of leucocytes in blood.
- Z-1570-2016 — BD Trucount Absolute Counting Tubes: Model number: 340334 IVD; BD Trucount tubes are used for determining absolute counts of leucocytes in blood. BD Trucount tubes are designed for use with in vitro diagnostic products such as BD Tritest reagents, and a suitably equipped flow cytometer. BD Trucount tubes can be used with the BD FACS Loader.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K970836.
Data sourced from openFDA. This site is unofficial and independent of the FDA.