The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Synchron Lx 20 Clinical Chemistry System, Synchron Lx Albumin Reagent, Synchron Lx Creatinine Picric Reagent, Synchron L.
| Device ID | K965240 |
| 510k Number | K965240 |
| Device Name: | SYNCHRON LX 20 CLINICAL CHEMISTRY SYSTEM, SYNCHRON LX ALBUMIN REAGENT, SYNCHRON LX CREATININE PICRIC REAGENT, SYNCHRON L |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| 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 | JJE |
| Subsequent Product Code | CDS |
| Subsequent Product Code | CEK |
| Subsequent Product Code | CEM |
| Subsequent Product Code | CEO |
| Subsequent Product Code | CGA |
| Subsequent Product Code | CGX |
| Subsequent Product Code | CGZ |
| Subsequent Product Code | CIX |
| Subsequent Product Code | JFL |
| Subsequent Product Code | JFP |
| Subsequent Product Code | JGS |
| Subsequent Product Code | JIX |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-03-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590233259 | K965240 | 000 |