The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for System 6300 Series High Performance Amino Acid Ana.
| Device ID | K925093 |
| 510k Number | K925093 |
| Device Name: | SYSTEM 6300 SERIES HIGH PERFORMANCE AMINO ACID ANA |
| Classification | Analyzer, Chemistry, Micro, For Clinical Use |
| Applicant | BECKMAN INSTRUMENTS, INC. 1050 PAGE MILL RD. BO 10200 Palo Alto, CA 94303 |
| Contact | Robert H Slocum |
| Correspondent | Robert H Slocum BECKMAN INSTRUMENTS, INC. 1050 PAGE MILL RD. BO 10200 Palo Alto, CA 94303 |
| Product Code | JJF |
| CFR Regulation Number | 862.2170 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-07 |
| Decision Date | 1993-11-16 |