The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Cholinesterase (chex) Model A53722.
| Device ID | K103373 |
| 510k Number | K103373 |
| Device Name: | SYNCHRON SYSTEMS CHOLINESTERASE (CHEX) MODEL A53722 |
| Classification | Colorimetry, Cholinesterase |
| Applicant | BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD Brea, CA 92821 |
| Contact | Yvette Lloyd |
| Correspondent | Yvette Lloyd BECKMAN COULTER, INC. 250 S. KRAEMER BOULEVARD Brea, CA 92821 |
| Product Code | DIH |
| CFR Regulation Number | 862.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-02-07 |
| Summary: | summary |