510(k) K200256 ยท PDJ Hemoglobin A1c Test System
ADVIA Chemistry Enzymatic Hemoglobin Ale (Alc_E) Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Tarrytown NY, US |
| Decision | Substantially Equivalent, Jul 2, 2021 |
| Received | Feb 3, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K200256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 8, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E). Material Number: 11097536. Open, Classified |
PDJ | None listed |
| Mar 27, 2026 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E);
Siemens Material Number (SMN): 11097536; Open, Classified |
PDJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.