The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems High Sensitivity Cardiac C-reactive Protein (crph) Reagent.
| Device ID | K070626 |
| 510k Number | K070626 |
| Device Name: | SYNCHRON SYSTEMS HIGH SENSITIVITY CARDIAC C-REACTIVE PROTEIN (CRPH) REAGENT |
| Classification | Cardiac C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. Brea, CA 92821 |
| Contact | Tara Viviani |
| Correspondent | Tara Viviani BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. Brea, CA 92821 |
| Product Code | NQD |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-03-06 |
| Decision Date | 2007-05-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590228682 | K070626 | 000 |