The following data is part of a premarket notification filed by Syva Co. with the FDA for Abbott Aeroset Carbamazepine Assay And Calibrators; Models 1e12 And 6e90.
| Device ID | K993028 |
| 510k Number | K993028 |
| Device Name: | ABBOTT AEROSET CARBAMAZEPINE ASSAY AND CALIBRATORS; MODELS 1E12 AND 6E90 |
| Classification | Enzyme Immunoassay, Carbamazepine |
| Applicant | SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Contact | Paul L Rogers |
| Correspondent | Paul L Rogers SYVA CO. 3403 YERBA BUENA RD. San Jose, CA 95161 -9013 |
| Product Code | KLT |
| CFR Regulation Number | 862.3645 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-09 |
| Decision Date | 2000-01-27 |
| Summary: | summary |