The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl 6000 System (acl 6000).
| Device ID | K961991 |
| 510k Number | K961991 |
| Device Name: | ACL 6000 SYSTEM (ACL 6000) |
| Classification | Instrument, Coagulation, Automated |
| Applicant | INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Contact | Betty J Lane |
| Correspondent | Betty J Lane INSTRUMENTATION LABORATORY CO. 113 HARTWELL AVE. Lexington, MA 02173 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-05-21 |
| Decision Date | 1996-09-04 |