The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite/immulite 1000 Progesterone Calibration Verification (cvm).
| Device ID | K103683 |
| 510k Number | K103683 |
| Device Name: | IMMULITE/IMMULITE 1000 PROGESTERONE CALIBRATION VERIFICATION (CVM) |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Garo Mimaryan |
| Correspondent | Garo Mimaryan SIEMENS HEALTHCARE DIAGNOSTICS 511 Benedict Avenue Tarrytown, NY 10591 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-04-28 |
| Summary: | summary |