510(k) K011434 ยท LCP Assay, Glycosylated Hemoglobin
G7 AUTOMATED HPLC ANALYZER
| Applicant | Tosoh Medics, Inc., South San Francisco CA, US |
| Decision | Substantially Equivalent, Sep 18, 2001 |
| Received | May 10, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K011434
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2015 | Tosoh Bioscience, Inc. G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HLC 723G7.
Product Usage:
G7 Variant Elution Buffer HiS No 1. (M) is one of the buffers used on Toso Terminated |
LCP | None listed |
| Apr 10, 2013 | Tosoh Bioscience Inc G7 HPLC.
Used as an aid in the detection and presumptive identification of abnormal hemoglobins in whole blood. Terminated |
JPD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.