ACL TOP
Instrument, Coagulation, Automated
INSTRUMENTATION LABORATORY CO.
The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top.
Pre-market Notification Details
| Device ID | K063679 |
| 510k Number | K063679 |
| Device Name: | ACL TOP |
| 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 | 2006-12-11 |
| Decision Date | 2007-01-12 |
| Summary: | summary |
Trademark Results [ACL TOP]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACL TOP 76426618 2792612 Live/Registered |
Instrumentation Laboratory Company 2002-07-01 |
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