FDA device listing
G8 90 SL,G8 Variant Elution Buffer No. 1,G8 Variant Elution Buffer No. 2,G8 Variant Elution Buffer No. 3,HbA1c…
FDA device listing 1240554016 · TOSOH BIOSCIENCE
Key facts
| Proprietary names | G8 90 SL,G8 Variant Elution Buffer No. 1,G8 Variant Elution Buffer No. 2,G8 Variant Elution Buffer No. 3,HbA1c Calibrator Set,HLC-723G8,Tosoh Automated Glycohemoglobin Analyzer HLC-723G8,Tosoh Automated Glycohemoglobin Analyzer HLC-723G8 LA,TSKgel G8 Variant |
|---|---|
| Owner/operator | TOSOH BIOSCIENCE |
| Owner/operator number | 8031673 |
| Premarket submissions | K071132 |
| Product codes | JIS, LCP |
| Device names | JIS - Calibrator, Primary, LCP - Assay, Glycosylated Hemoglobin |
| Device class | Class II |
| Classification regulations (21 CFR) | 862.1150, 864.7470 |
| Review panels | Clinical Chemistry, Hematology |
| Registered establishments | TOSOH BIOSCIENCE, INC., TOSOH CORP., Tosoh Hi-Tec, Inc. |
| Establishment registrations | 8031673, 3004529019, 3005529799 |
| FEI numbers | 2967, 3004529019, 3005529799 |
| Establishment operations | Complaint File Establishment, Repackager/Relabeler, Foreign Exporter, Manufacturer |
| Registration valid through | 2026 |
At a glance
- 1–9 Registered establishments listing this device
- None UDI devices (GUDID) under the same submission
- 1–9 Device listings citing the same submission
- Yes Premarket submission listed
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device listings
Establishments that make or process devices for the U.S. market must list each device with the FDA. A listing records the device's proprietary names, product codes and premarket submission, and every registered establishment that handles it.
Source: U.S. Food and Drug Administration (FDA), Establishment Registration and Device Listing database