The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top Model, Top.
| Device ID | K033414 |
| 510k Number | K033414 |
| Device Name: | ACL TOP MODEL, TOP |
| Classification | Instrument, Coagulation, Automated |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Carol Marble |
| Correspondent | Carol Marble INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-10-27 |
| Decision Date | 2004-01-12 |
| Summary: | summary |