ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay— 510(k) K171771
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K171771 for ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay, Substantially Equivalent on 2017-12-04. Applicant: Siemens Healthcare Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics, 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
- Newark, DE, US
Recent devices under product code PDJ
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K171771
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K171771.
Data sourced from openFDA. This site is unofficial and independent of the FDA.