The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Propoxyphene Reagent.
| Device ID | K955675 |
| 510k Number | K955675 |
| Device Name: | SYNCHRON SYSTEMS PROPOXYPHENE REAGENT |
| Classification | Enzyme Immunoassay, Propoxyphene |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | JXN |
| CFR Regulation Number | 862.3700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-02-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222963 | K955675 | 000 |