510(k) K083420 ยท GKZ Counter, Differential Cell
MEDONIC M SERIES
| Applicant | Boule Medical AB, Plantation FL, US |
| Decision | Substantially Equivalent, Feb 3, 2009 |
| Received | Nov 19, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2020 | Clinical Diagnostic Solutions, Inc. Medonic M-Series Hematology Analyzer
M16S BD ABR US
Product code: 1400075;
OUS Product code 1400011 Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.