ACL AcuStar
System, Multipurpose For In Vitro Coagulation Studies
INSTRUMENTATION LABORATORY CO.
The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Acustar.
Pre-market Notification Details
| Device ID | K170314 |
| 510k Number | K170314 |
| Device Name: | ACL AcuStar |
| Classification | System, Multipurpose For In Vitro Coagulation Studies |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 |
| Contact | Nikita Malladi |
| Correspondent | Nikita Malladi 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 | 2017-02-01 |
| Decision Date | 2017-03-03 |
| Summary: | summary |
Trademark Results [ACL AcuStar]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACL ACUSTAR 77097938 3781511 Live/Registered |
Instrumentation Laboratory Company 2007-02-02 |
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