The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Multiconstituent Calibrator.
| Device ID | K103403 |
| 510k Number | K103403 |
| Device Name: | MULTICONSTITUENT CALIBRATOR |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ABBOTT LABORATORIES 1921 HURD DRIVE Irving, TX 75038 -4396 |
| Contact | Linda Morris |
| Correspondent | Linda Morris ABBOTT LABORATORIES 1921 HURD DRIVE Irving, TX 75038 -4396 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-19 |
| Decision Date | 2011-02-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740101220 | K103403 | 000 |
| 00380740000431 | K103403 | 000 |