Data / Medical devices / United States / Clinical Diagnostic Solutions, Inc.
Clinical Diagnostic Solutions, Inc.: FDA-registered device maker in Plantation, FL, United States, 2 510(k) clearances
Clinical Diagnostic Solutions, Inc. is registered with the FDA (registration 1064130) in Plantation, FL, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated June 10, 2004. 4 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1064130
- FEI number
- 3002684533
- Address
- 1800 N.W. 65TH Ave., Plantation, FL, United States, 33313
- Owner or operator
- Boule Diagnostics AB (9034165)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 8, 1999
- Registered through
- 2026
- Brand names listed
- 501-002 ENZYMATIC CLEANER, 501-003 HEMATOLOGY DILUENT, 501-009 CDS 5-PD Reagent Set, 501-028 Ac T Diff Reagent Pack, 501-029 Ac.T Cleaner and Shutdown Solution, 501-032 ENZYMATIC CLEANER, 501-036 Boule Cleaning Kit, 501-050 CDS SHEATH REAGENT and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator For Hemoglobin And Hematocrit Measurement | KRZ | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Calibrator For Platelet Counting | KRY | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Calibrator For Red-Cell And White-Cell Counting | KSA | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Detergent | JCB | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Diluent, Blood Cell | GIF | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Flow Cytometric Reagents And Accessories. | OYE | 2 | Contract manufacturer | accessdata.fda.gov |
| Formulations, Balanced Salt Solutions | KIP | 1 | Manufacturer | accessdata.fda.gov |
| General Purpose Reagent | PPM | 1 | Manufacturer | accessdata.fda.gov |
| Mixture, Hematology Quality Control | JPK | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Products, Red-Cell Lysing Products | GGK | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 10, 2004 | K041130 | CDS HEMATOLOGY CALIBRATOR (CDS CAL) | KRZ | Substantially Equivalent | Clinical Diagnostic Solutions, Inc. | accessdata.fda.gov |
| January 14, 2003 | K024173 | CDS 3-PD HEMATOLOGY CONTROLS | JPK | Substantially Equivalent | Clinical Diagnostic Solutions, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 2, 2020 | 84614 | Class II | Terminated | Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011 | A mix-up of autosampler tube positions with a possibility of misidentification of sample results and a risk of operator injury from an exposed aspiration needle. | accessdata.fda.gov |
| February 24, 2013 | 67724 | Class II | Terminated | 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. | Elevated MCV results on the 1311-682, 1311-683, and 1311-684 lots. | accessdata.fda.gov |
| March 24, 2011 | 63096 | Class III | Terminated | Boule Con-Diff Hematology Control For in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled Boule Con Diff US Tri Pack (Product Part, Lot #1102-575 and 1102-576; Product Part, Lot #1102-576; and Product Part, Lot #1102-574) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was initiated due to the rece | accessdata.fda.gov |
| August 4, 2010 | 63094 | Class III | Terminated | 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. | Clinical Diagnostic Solutions, Inc. in Plantation, FL recalled the Boule Con Diff US Tri Pack (Product part, Lot #1005-549 and Product part, Lot #1005-549) which is used for in vitro diagnostic use as a control to monitor the performance of multi-parameter hematology instruments. The recall was imitated due to receipt of customers stating the MCV values and | accessdata.fda.gov |
Compare with other makers
- All makers of Products, Red-Cell Lysing Products
- All makers of Detergent
- All makers of Formulations, Balanced Salt Solutions
- All makers of Diluent, Blood Cell
- All makers of General Purpose Reagent
- All makers of Mixture, Hematology Quality Control
Updated June 10, 2004. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.