The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Cannabinoid 20 Ng Reagent.
| Device ID | K955677 |
| 510k Number | K955677 |
| Device Name: | SYNCHRON SYSTEMS CANNABINOID 20 NG REAGENT |
| Classification | Enzyme Immunoassay, Cannabinoids |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 S. KRAEMER BLVD., W-337 Brea, CA 92622 -8000 |
| Contact | Sheri Hall |
| Correspondent | Sheri Hall BECKMAN INSTRUMENTS, INC. 200 S. KRAEMER BLVD., W-337 Brea, CA 92622 -8000 |
| Product Code | LDJ |
| CFR Regulation Number | 862.3870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-04-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590231644 | K955677 | 000 |
| 15099590224851 | K955677 | 000 |