510(k) K200256
K200256 is an FDA 510(k) premarket notification submitted by Siemens Healthcare Diagnostics, Inc. for the device "ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay". The FDA issued a decision of Substantially Equivalent on July 2, 2021. The device falls under product code PDJ (Hemoglobin A1c Test System), a Class II device regulated under 21 CFR 862.1373. Siemens Healthcare Diagnostics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 2021
- Date Received
- February 3, 2020
- Clearance Type
- Special
- 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
Quantitative determination of Hemoglobin A1c to aid in the diagnosis of diabetes.