The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Modification To Synchron Systems Enzyme Validator Set Levels 1 And 2.
| Device ID | K032287 |
| 510k Number | K032287 |
| Device Name: | MODIFICATION TO SYNCHRON SYSTEMS ENZYME VALIDATOR SET LEVELS 1 AND 2 |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Contact | Kim Walker |
| Correspondent | Kim Walker BECKMAN COULTER, INC. 200 S. KRAEMER BLVD.,M/S W-104 BOX 8000 Brea, CA 92822 -8000 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-07-24 |
| Decision Date | 2003-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223465 | K032287 | 000 |