The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Paragon Cze 2000 Clinical Capillary Electrophoresis System.
| Device ID | K953077 |
| 510k Number | K953077 |
| Device Name: | PARAGON CZE 2000 CLINICAL CAPILLARY ELECTROPHORESIS SYSTEM |
| Classification | Acid, Vanilmandelic, Diazo, P-nitroaniline/vanillin |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Contact | Sheri L Hall |
| Correspondent | Sheri L Hall BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. W-337 Brea, CA 92821 -6208 |
| Product Code | CDF |
| Subsequent Product Code | CFF |
| Subsequent Product Code | JQT |
| CFR Regulation Number | 862.1795 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-30 |
| Decision Date | 1996-01-05 |