CDS 3-PD HEMATOLOGY CONTROLS— 510(k) K024173
Substantially EquivalentClinical Diagnostic Solutions, Inc.
FDA 510(k) clearance K024173 for CDS 3-PD HEMATOLOGY CONTROLS, Substantially Equivalent on 2003-01-14. Applicant: Clinical Diagnostic Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Clinical Diagnostic Solutions, Inc.
- 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
- Plantation, FL, US
Recent devices under product code JPK
view allMore clearances from Clinical Diagnostic Solutions, Inc.
view allRecalls naming K024173
K-number listed on FDA's recall record- Z-1436-2014 — Boule Con-Diff Tri-Level Multi-Parameter Assayed Hematology Control, used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Z-0207-2013 — Trochar Scalpel Instrument (Surgical Punch) OrthoPediatrics intramedullary rods (nails) are generally rod-shaped devices, with screw holes at either end for fixation to bone. This device is intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments. Additional stabilization may be realized by installing transverse screws through holes in the rod. These devices are made of medical grade stainless steel. The OrthoPediatrics PediNail" system is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.
- Z-0189-2013 — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Z-0190-2013 — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Z-0191-2013 — Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Z-0193-2013 — Boule Con Diff US Tri Pack, 6 Vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
- Z-0194-2013 — Boule Con-Diff Hematology Control 9 vials. For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K024173.
Data sourced from openFDA. This site is unofficial and independent of the FDA.