The following data is part of a premarket notification filed by Beckman-diagnostic Systems Group with the FDA for Cx Opiate Reagent For Synchron Cx Systems.
| Device ID | K944606 |
| 510k Number | K944606 |
| Device Name: | CX OPIATE REAGENT FOR SYNCHRON CX SYSTEMS |
| Classification | Enzyme Immunoassay, Opiates |
| Applicant | BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN-DIAGNOSTIC SYSTEMS GROUP 200 S. KRAEMER BLVD., W-337 BOX 8000 Brea, CA 92821 -6208 |
| Product Code | DJG |
| CFR Regulation Number | 862.3650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-19 |
| Decision Date | 1994-11-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222970 | K944606 | 000 |