The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems C-reactive Protein (crp) Reagent.
| Device ID | K974050 |
| 510k Number | K974050 |
| Device Name: | SYNCHRON SYSTEMS C-REACTIVE PROTEIN (CRP) REAGENT |
| Classification | C-reactive Protein, Antigen, Antiserum, And Control |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | DCK |
| CFR Regulation Number | 866.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-10-24 |
| Decision Date | 1997-11-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590225391 | K974050 | 000 |