The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top 700 Las.
| Device ID | K091980 |
| 510k Number | K091980 |
| Device Name: | ACL TOP 700 LAS |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-01 |
| Decision Date | 2009-09-22 |
| Summary: | summary |