510(k) K024173 ยท JPK Mixture, Hematology Quality Control
CDS 3-PD HEMATOLOGY CONTROLS
| Applicant | Clinical Diagnostic Solutions, Inc., Plantation FL, US |
| Decision | Substantially Equivalent, Jan 14, 2003 |
| Received | Dec 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K024173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2014 | Clinical Diagnostic Solutions 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. Terminated |
JPK | None listed |
| Nov 5, 2012 | Clinical Diagnostic Solutions 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. Terminated |
JPK | None listed |
| Nov 5, 2012 | Clinical Diagnostic Solutions Boule Con-Diff Hematology Control 9 vials.
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Terminated |
JPK | None listed |
| Nov 5, 2012 | OrthoPediatrics Corp 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 Terminated |
HSB | None listed |
| Nov 2, 2012 | Clinical Diagnostic Solutions Boule Con-Diff Hematology Control
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Terminated |
JPK | None listed |
| Nov 2, 2012 | Clinical Diagnostic Solutions Boule Con-Diff Hematology Control
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Terminated |
JPK | None listed |
| Nov 2, 2012 | Clinical Diagnostic Solutions Boule Con-Diff Hematology Control
For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. Terminated |
JPK | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.