The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Methadone Reagent.
| Device ID | K973069 |
| 510k Number | K973069 |
| Device Name: | SYNCHRON SYSTEMS METHADONE REAGENT |
| Classification | Enzyme Immunoassay, Methadone |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Lucinda Stockert |
| Correspondent | Lucinda Stockert BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | DJR |
| CFR Regulation Number | 862.3620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222994 | K973069 | 000 |