The following data is part of a premarket notification filed by Clinical Diagnostic Solutions, Inc. with the FDA for Cds 3-pd Hematology Controls.
| Device ID | K024173 |
| 510k Number | K024173 |
| Device Name: | CDS 3-PD HEMATOLOGY CONTROLS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Contact | Andrew C Swanson |
| Correspondent | Andrew C Swanson CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-18 |
| Decision Date | 2003-01-14 |