The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Immage Immunochemistry System C-reactive Protein (crp) Reagent.
| Device ID | K981638 |
| 510k Number | K981638 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM C-REACTIVE PROTEIN (CRP) REAGENT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-05-08 |
| Decision Date | 1998-06-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590231910 | K981638 | 000 |