The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Benzodiazepine (bnzg) Reagent.
| Device ID | K043556 |
| 510k Number | K043556 |
| Device Name: | SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT |
| Classification | Enzyme Immunoassay, Benzodiazepine |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | JXM |
| CFR Regulation Number | 862.3170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-12-27 |
| Decision Date | 2005-03-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590202026 | K043556 | 000 |