Chemiluminescent Immunoassay System
Device Code: 6297
Product Code(s):
PKM Definition: For In Vitro Diagnostic Use In The Quantitative Measurement Of Hyaluronic Acid In Human Serum.
Device Classification Information
| Device Type ID | 6297 |
| Device Name | Chemiluminescent Immunoassay System |
| Physical State | N/a |
| Technical Method | Chemiluminescent Immunoassay |
| Target Area | In Vitro |
| Review Panel | Toxicology |
| Premarket Review | Office Of In Vitro Diagnostics And Radiological Health (OIR)
|
| Submission Type | Enforcement Discretion |
| FDA Device Classification | Class Not Classified Medical Device |
| Product Code | PKM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
Recognized Standards
Total Product Life Cycle
| Device Type ID | 6297 |
| Device | Chemiluminescent Immunoassay System |
| Product Code | PKM |
TPLC Last Update: 2019-04-02 21:20:01