510(k) K071132 ยท LCP Assay, Glycosylated Hemoglobin
G8 AUTOMATED HPLC ANALYZER, MODEL HLC-723 G8
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Sep 16, 2008 |
| Received | Apr 23, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071132
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 7, 2016 | Tosoh Bioscience, Inc. Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing. Terminated |
JCM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.