510(k) K200904
K200904 is an FDA 510(k) premarket notification submitted by Tosoh Bioscience, Inc. for the device "Tosoh Automated Glycohemoglobin Analyzer HLC-723G8". The FDA issued a decision of Substantially Equivalent on Aug 5, 2021. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Tosoh Bioscience, Inc. has 19 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 5, 2021
- Date Received
- Apr 6, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Hemoglobin A1c Test System
- Device Class
- Class II
- Regulation Number
- 862.1373
- Review Panel
- CH
- Submission Type
- 510(k)
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.