510(k) K100304 ยท LCP Assay, Glycosylated Hemoglobin
ST AIA PACK HBA1C
| Applicant | Tosoh Bioscience, Inc., South San Franciso CA, US |
| Decision | Substantially Equivalent, Aug 27, 2010 |
| Received | Feb 3, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100304
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 6, 2018 | Tosoh Bioscience Inc G8 Automated HPLC Analyzer: HLC-723G8-ST, 021560; and HLC-723G8-LA, 021674
Product Usage:
The Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 is intended for in vitro diagnostic use for the quanti Terminated |
LCP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc Tosoh ST AIA-PACK HbA1c, HbA1c Reagent, Pt. No. 025218
The device is designed for In Vitro Diagnostic Use Only for the quantitative measurement for percent concentration of Hemoglobin A1c (HbA1c) in Terminated |
LCP | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc Tosoh ST AIA-PACK HbA1c Calibrator, HbA1c Calibrator, PN 025318
The product is intended for In Vitro Diagnostic Use Only for the calibration of the HbA1c Assay. Terminated |
JIT | None listed |
| Mar 5, 2018 | Tosoh Bioscience Inc Tosoh ST AIA-PACK HbA1c Pretreatment Solution, HbA1c Pretreatment Solution, PN 025718
The device is intended for In Vitro Diagnostic Use Only for the pretreatment of the patient samples or control se Terminated |
N/A | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.