The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Elite; Acl Elite Pro.
| Device ID | K060162 |
| 510k Number | K060162 |
| Device Name: | ACL ELITE; ACL ELITE PRO |
| 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 | 2006-01-23 |
| Decision Date | 2006-02-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950965572 | K060162 | 000 |
| 08426950453482 | K060162 | 000 |
| 08426950453017 | K060162 | 000 |
| 08426950451570 | K060162 | 000 |