The following data is part of a premarket notification filed by Beckman Coulter, Inc. with the FDA for Synchron Systems Vancomycin Reagent; Synchron Systems Vancomycin Calibrator.
| Device ID | K013076 |
| 510k Number | K013076 |
| Device Name: | SYNCHRON SYSTEMS VANCOMYCIN REAGENT; SYNCHRON SYSTEMS VANCOMYCIN CALIBRATOR |
| Classification | Radioimmunoassay, Vancomycin |
| Applicant | BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Contact | Mary Beth Tang |
| Correspondent | Mary Beth Tang BECKMAN COULTER, INC. 200 SOUTH KRAEMER BLVD. W-110 Brea, CA 92822 |
| Product Code | LEH |
| CFR Regulation Number | 862.3950 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-09-14 |
| Decision Date | 2001-12-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590223342 | K013076 | 000 |
| 15099590222123 | K013076 | 000 |