510(k) K911385 ยท GKZ Counter, Differential Cell
COULTER(R) MH010
| Applicant | Coulter Electronics, Inc., Hialeah FL, US |
| Decision | Substantially Equivalent, Jun 17, 1991 |
| Received | Mar 28, 1991 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K911385
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 18, 2011 | Beckman Coulter Inc. Coulter MAXM Hematology Analyzer and MAXM Hematology Analyzer with Autoloader.
Hematology Analyzers; Part Number: 6604569, 6604687, 6705995, 6705996, 6705997, 6705998, 6705999, and 6706000.
Quantita Terminated |
GKZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.