The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Abbott Architect Lh Calibrators.
| Device ID | K111023 |
| 510k Number | K111023 |
| Device Name: | ABBOTT ARCHITECT LH CALIBRATORS |
| Classification | Calibrator, Secondary |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Contact | John Rizos |
| Correspondent | John Rizos ABBOTT LABORATORIES 100 ABBOTT PARK ROAD DEPT 9V6, AP5N-2 Abbott Park, IL 60064 |
| Product Code | JIT |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-13 |
| Decision Date | 2011-06-10 |
| Summary: | summary |