The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top (with System Software V3.0.0).
| Device ID | K073377 |
| 510k Number | K073377 |
| Device Name: | ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-05-04 |
| Summary: | summary |