K121445 is an FDA 510(k) clearance for the TETRACHROME REAGENTS AND TETRACXP SYSTEM. This device is classified as a Flow Cytometric Reagents And Accessories. (Class II - Special Controls, product code OYE).
Submitted by Beckman Coulter, Inc. (Miami, US). The FDA issued a Cleared decision on July 26, 2013, 437 days after receiving the submission on May 15, 2012.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5220. To Identify And Classify Cells Or Other Particles In Suspension By Their Inherent Physical Properties Or Associated Fluorescent Molecules In Order To Provide Information About The Distribution Or Number Cells In Suspension Or Their Level Of Protein Expression. These Characteristics May Aid In The Diagnosis Of Conditions Such As Immunodeficiency And Cancer..
| 510(k) Number | K121445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 15, 2012 |
| Decision Date | July 26, 2013 |
| Days to Decision | 437 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | OYE — Flow Cytometric Reagents And Accessories. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5220 |
| Definition | To Identify And Classify Cells Or Other Particles In Suspension By Their Inherent Physical Properties Or Associated Fluorescent Molecules In Order To Provide Information About The Distribution Or Number Cells In Suspension Or Their Level Of Protein Expression. These Characteristics May Aid In The Diagnosis Of Conditions Such As Immunodeficiency And Cancer. |