The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Modification Of Acl Advance.
| Device ID | K002400 |
| 510k Number | K002400 |
| Device Name: | MODIFICATION OF ACL ADVANCE |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-04 |
| Decision Date | 2000-08-30 |