ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay— 510(k) K200256
Substantially EquivalentSiemens Healthcare Diagnostics, Inc.
FDA 510(k) clearance K200256 for ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay, Substantially Equivalent on 2021-07-02. 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
- Special
- Location
- Tarrytown, NY, US
Recent devices under product code PDJ
view allMore clearances from Siemens Healthcare Diagnostics, Inc.
view allRecalls naming K200256
K-number listed on FDA's recall record- Z-2703-2026 — Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536.
- Z-1657-2026 — Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200256.
Data sourced from openFDA. This site is unofficial and independent of the FDA.