Company ยท US
Clinical Diagnostic Solutions
FDA 510(k) clearances and medical device recalls filed under this name, 1999 to 2004. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
7recalls (0 in 12 months)
7recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 10, 2004 | K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) Clinical Diagnostic Solutions, Inc. | KRZ |
| Jan 14, 2003 | K024173 | CDS 3-PD HEMATOLOGY CONTROLS Clinical Diagnostic Solutions, Inc. | JPK |
| Dec 20, 1999 | K993375 | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER Clinical Diagnostic Solutions, Inc. | KRX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2020 | Clinical Diagnostic Solutions, Inc. Medonic M-Series Hematology Analyzer
M16S BD ABR US
Product code: 1400075;
OUS Product code 1400011 Terminated |
GKZ | K083420 |
| 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 | K024173 |
| 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 | K024173 |
| 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 | K024173 |
| 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 | K024173 |
| 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 | K024173 |
| 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 | K024173 |