The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Opiates 2000 Ng (op2) Reagent.
| Device ID | K984152 |
| 510k Number | K984152 |
| Device Name: | SYNCHRON SYSTEMS OPIATES 2000 NG (OP2) REAGENT |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-11-19 |
| Decision Date | 1999-01-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222031 | K984152 | 000 |