510(k) K962988 ยท GKL Counter, Cell, Automated (Particle Counter)
COULTER GEN-S SYSTEM
| Applicant | Coulter Corp., Miami FL, US |
| Decision | Substantially Equivalent, Oct 30, 1996 |
| Received | Aug 1, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962988
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 12, 2011 | Beckman Coulter Inc. Coulter GEN's
The COULTER LH 500 Analyzer is a quantitative, automated hematology analyzer and leukocyte differential cell counter for In Vitro Diagnostic Use in clinical laboratories. The LH500 Anal Terminated |
GKL | None listed |
| Dec 22, 2007 | Beckman Coulter Inc COULTER GEN*S System, Part Number: 6605381, Beckman Coulter, Brea, CA. (Hematology analyzer) Terminated |
GKL | None listed |
| Feb 4, 2006 | Beckman Coulter Inc COULTER GEN.S Series Hematology Analyzer, PN 6605632, 6605632R; GENS: 6605381, 6605381R, 6605360, 6605360R, 6605470, 6605470R Terminated |
GKJ | None listed |
| Feb 25, 2003 | Beckman Coulter Inc Coulter LH 700 Series and GEN S Hematology Analyzers
864.5220 Automated differential cell counter Terminated |
None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.