510(k) K052905 ยท GKZ Counter, Differential Cell
MODIFICATION TO COULTER LH 750 HEMATOLOGY ANALYZER
| Applicant | Beckman Coulter, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Nov 18, 2005 |
| Received | Oct 14, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 26, 2017 | Beckman Coulter Inc. Coulter LH 750, Coulter LH 780, and Coulter LH 500 Analyzers
Hematology Analyzers are quantitative, automated hematology analyzers and leukocyte differential counters For In Vitro Diagnostic used in Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.