The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl 9000 System.
| Device ID | K000053 |
| 510k Number | K000053 |
| Device Name: | ACL 9000 SYSTEM |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| 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 | JPA |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-07 |
| Decision Date | 2000-03-15 |