The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Lipid Multi Constituent Calibrator.
| Device ID | K123372 |
| 510k Number | K123372 |
| Device Name: | ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1921 HURD DR. Irving, TX 75038 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-11-01 |
| Decision Date | 2013-01-14 |
| Summary: | summary |