ST AIA PACK HBA1C— 510(k) K100304
Substantially EquivalentTosoh Bioscience, Inc.
FDA 510(k) clearance K100304 for ST AIA PACK HBA1C, Substantially Equivalent on 2010-08-27. Applicant: Tosoh Bioscience, Inc.. Device class: 2.
Clearance details
- Applicant
- Tosoh Bioscience, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- South San Franciso, CA, US
Recent devices under product code LCP
view allMore clearances from Tosoh Bioscience, Inc.
view allRecalls naming K100304
K-number listed on FDA's recall record- Z-2745-2018 — 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 quantitative measurement of % hemoglobin A1c (HbA1c) (DCCT/NGSP) and mmol/mol hemoglobin A1c (IFCC) in whole blood specimens. This test is to be used as an aid in diagnosis of diabetes and as an aid in identifying patients who may be at risk for developing diabetes.
- Z-1809-2018 — 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 EDTA whole blood on Tosoh AIA System Analyzer. HbA1c measurement is used in the management and treatment of diabetes.
- Z-1810-2018 — 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.
- Z-1812-2018 — 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 set for the HbA1c assay
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K100304.
Data sourced from openFDA. This site is unofficial and independent of the FDA.