The following data is part of a premarket notification filed by Siemens Medical Solutions Diagnostics with the FDA for Immulite 2500 High Sensitivity C-reactive Protein, Models L5kcrp (200 Tests), L5kcrp (600 Tests).
| Device ID | K071017 |
| 510k Number | K071017 |
| Device Name: | IMMULITE 2500 HIGH SENSITIVITY C-REACTIVE PROTEIN, MODELS L5KCRP (200 TESTS), L5KCRP (600 TESTS) |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Contact | Deborah L Morris |
| Correspondent | Deborah L Morris SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS 5210 PACIFIC CONCOURSE DR. Los Angeles, CA 90045 -6900 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-10 |
| Decision Date | 2007-05-02 |
| Summary: | summary |