510(k) K152776 ยท GKL Counter, Cell, Automated (Particle Counter)
Glocyte Automated Cell Counter System
| Applicant | Advanced Instruments, Inc., Norwood MA, US |
| Decision | Substantially Equivalent, May 27, 2016 |
| Received | Sep 25, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152776
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2018 | Advanced Instruments, LLC GloCyte RBC Reagent - Product Usage: The GloCyte Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of Terminated |
GKL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.