The following data is part of a premarket notification filed by Clinical Diagnostic Solutions, Inc. with the FDA for Cds Hematology Calibrator (cds Cal).
| Device ID | K041130 |
| 510k Number | K041130 |
| Device Name: | CDS HEMATOLOGY CALIBRATOR (CDS CAL) |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Contact | Andrew Swanson |
| Correspondent | Andrew Swanson CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Product Code | KRZ |
| Subsequent Product Code | KRY |
| Subsequent Product Code | KSA |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-04-30 |
| Decision Date | 2004-06-10 |