The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Enhanced Estradiol (ee2) Master Curve Material.
| Device ID | K102904 |
| 510k Number | K102904 |
| Device Name: | ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 BENEDICT AVENUE Tarrytown, NY 10591 -5097 |
| Contact | Clare Santulli |
| Correspondent | Clare Santulli 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 | 2010-10-01 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414598888 | K102904 | 000 |
| 00630414578972 | K102904 | 000 |