AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8— 510(k) K131580
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K131580 for AUTOMATED GYLCOHEMOGLOBIN ANALYZER HLC-723G8, Substantially Equivalent on 2014-01-23. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code PDJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1373
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Franciso, CA, US
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Recalls naming K131580
K-number listed on FDA's recall record- Z-3244-2018 — 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 diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
- Z-1225-2017 — Tosoh Bioscience HLC-723G8 Analyzer for HbA1c testing.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131580.
Data sourced from openFDA. This site is unofficial and independent of the FDA.