510(k) K171771 ยท PDJ Hemoglobin A1c Test System
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
| Applicant | Siemens Healthcare Diagnostics, Inc., Newark DE, US |
| Decision | Substantially Equivalent, Dec 4, 2017 |
| Received | Jun 14, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K171771
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 9, 2022 | Siemens Healthcare Diagnostics, Inc. Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 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.