The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Quantex Crp High Sensitivity Standard Multipoint, Quantex Crp High Sensitivity Controls Ve Controls 1/2.
| Device ID | K032663 |
| 510k Number | K032663 |
| Device Name: | QUANTEX CRP HIGH SENSITIVITY STANDARD MULTIPOINT, QUANTEX CRP HIGH SENSITIVITY CONTROLS VE CONTROLS 1/2 |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | DCK |
| Subsequent Product Code | JIS |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-28 |
| Decision Date | 2003-12-19 |
| Summary: | summary |