The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Hemosil C-reactive Protein - High Sensitivity And High Sensitivity Controls.
| Device ID | K023269 |
| 510k Number | K023269 |
| Device Name: | HEMOSIL C-REACTIVE PROTEIN - HIGH SENSITIVITY AND HIGH SENSITIVITY CONTROLS |
| 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 |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-01 |
| Decision Date | 2002-12-23 |
| Summary: | summary |