COULTER LINEARITY CONTROL— 510(k) K955334
Substantially EquivalentCoulter Corp.
FDA 510(k) clearance K955334 for COULTER LINEARITY CONTROL, Substantially Equivalent on 1996-02-08. Applicant: Coulter Corp.. Device class: 2.
Clearance details
- Applicant
- Coulter Corp.
- Product code
- Code JPK
- Device class
- Class 2
- Regulation
- 21 CFR 864.8625
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code JPK
view allMore clearances from Coulter Corp.
view all- K993356 — COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES
- K991070 — COULTER Z2 ANALYZER
- K990327 — RETICONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS
- K990172 — TETRAONE SYSTEM FOR EPICS XL FLOW CYTOMETRY SYSTEMS WITH CYTO-STAT TETRACHROME CD45-FITC/CD4-RD1/CD8-ECD/CD3-PC5 MONOCLA
- K990352 — COULTER AC T DIFF 2 ANALYZER
Data sourced from openFDA. This site is unofficial and independent of the FDA.