The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Architect Icarbamazepine Icarbamazepine Reagents; Architect Icarbamazepine Calibrators.
| Device ID | K103627 |
| 510k Number | K103627 |
| Device Name: | ARCHITECT ICARBAMAZEPINE ICARBAMAZEPINE REAGENTS; ARCHITECT ICARBAMAZEPINE CALIBRATORS |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6, AP6C-2 Abbott Park, IL 60064 |
| Contact | Judith R Wallach |
| Correspondent | Judith R Wallach ABBOTT LABORATORIES 100 ABBOTT PARK RD. DEPT. 9V6, AP6C-2 Abbott Park, IL 60064 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740081935 | K103627 | 000 |
| 00380740081072 | K103627 | 000 |
| 00380740001834 | K103627 | 000 |