The following data is part of a premarket notification filed by Instrumentation Laboratory Co. with the FDA for Acl Top (acl Top 700, Acl Top 700 Cts, Acl Top 700 Las, Acl Top 500 Cts, Acl Top 300 Cts).
| Device ID | K160276 |
| 510k Number | K160276 |
| Device Name: | ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) |
| Classification | Instrument, Coagulation, Automated |
| Applicant | INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2441 |
| Contact | Nikita Malladi |
| Correspondent | Nikita Malladi INSTRUMENTATION LABORATORY CO. 180 HARTWELL ROAD Bedford, MA 01730 -2441 |
| Product Code | GKP |
| CFR Regulation Number | 864.5400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-02 |
| Decision Date | 2016-03-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950928027 | K160276 | 000 |
| 08426950451600 | K160276 | 000 |
| 08426950453499 | K160276 | 000 |
| 08426950497974 | K160276 | 000 |
| 08426950497981 | K160276 | 000 |
| 08426950497998 | K160276 | 000 |
| 08426950556916 | K160276 | 000 |
| 08426950928003 | K160276 | 000 |
| 08426950928010 | K160276 | 000 |
| 08426950927990 | K160276 | 000 |