The following data is part of a premarket notification filed by Clinical Diagnostic Solutions, Inc. with the FDA for Cds Ltx Control Latex Particle Suspension And Primer.
| Device ID | K993375 |
| 510k Number | K993375 |
| Device Name: | CDS LTX CONTROL LATEX PARTICLE SUSPENSION AND PRIMER |
| Classification | Calibrator For Cell Indices |
| Applicant | CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Contact | Colin Aldersley |
| Correspondent | Colin Aldersley CLINICAL DIAGNOSTIC SOLUTIONS, INC. 1660 N.W. 65TH AVE., SUITE 2 Plantation, FL 33313 |
| Product Code | KRX |
| Subsequent Product Code | KRY |
| Subsequent Product Code | KRZ |
| Subsequent Product Code | KSA |
| CFR Regulation Number | 864.8150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-07 |
| Decision Date | 1999-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00812137010261 | K993375 | 000 |
| 00812137010254 | K993375 | 000 |