The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Cvm, Unconjugated Estriol (ue3) Calibration Verification Material.
| Device ID | K110061 |
| 510k Number | K110061 |
| Device Name: | CVM, UNCONJUGATED ESTRIOL (UE3) CALIBRATION VERIFICATION MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Contact | Ernest Joseph |
| Correspondent | Ernest Joseph SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-10 |
| Decision Date | 2011-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414947921 | K110061 | 000 |