The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Systems Methaqualone Reagent.
| Device ID | K955676 |
| 510k Number | K955676 |
| Device Name: | SYNCHRON SYSTEMS METHAQUALONE REAGENT |
| Classification | Radioimmunoassay, Methaqualone |
| 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 | KXS |
| CFR Regulation Number | 862.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-15 |
| Decision Date | 1996-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590222987 | K955676 | 000 |