The following data is part of a premarket notification filed by Beckman Coulter Ireland Inc with the FDA for System Calibrater.
| Device ID | K141388 |
| 510k Number | K141388 |
| Device Name: | SYSTEM CALIBRATER |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea, CA 92821 |
| Contact | David G Davis |
| Correspondent | David G Davis BECKMAN COULTER IRELAND INC 250 S. KRAEMER BLVD. E1.SE.01 Brea, CA 92821 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-05-27 |
| Decision Date | 2014-07-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15099590131180 | K141388 | 000 |