510(k) K131580 ยท PDJ Hemoglobin A1c Test System
AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Jan 23, 2014 |
| Received | May 31, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K131580
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 13, 2018 | Tosoh Bioscience Inc G8 Automated HPLC Analyzer - 723G8
Product Usage - In vitro diagnostic use for the quantitative measurement of % hemoglobin A1c in whole blood specimens. This test is to be used as an aid in the diag Terminated |
LCP | None listed |
| 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.