The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Immunochemistry Systems High Sensitivity Cardiac C-reactive Protein (ccrp) Reagent.
| Device ID | K071002 |
| 510k Number | K071002 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CCRP) REAGENT |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. M/S W-110 Brea, CA 92822 -8000 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-09 |
| Decision Date | 2007-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590221256 | K071002 | 000 |
| 15099590203160 | K071002 | 000 |