510(k) K160276 ยท GKP Instrument, Coagulation, Automated
ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS)
| Applicant | Instrumentation Laboratory CO, Bedford MA, US |
| Decision | Substantially Equivalent, Mar 3, 2016 |
| Received | Feb 2, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160276
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 28, 2022 | Instrumentation Laboratory ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL:
Name Part Number
1.ACL TOP 300 CTS 00000280060
2. ACL TOP 300 CTS 00000280060R (Refurbished)
3. ACL TOP 350 CTS 00000280065
4. ACL TOP 500 CTS 00000 Open, Classified |
GKP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.