The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 1000 Third Generation Psa Calibration Verification Material.
| Device ID | K122534 |
| 510k Number | K122534 |
| Device Name: | IMMULITE 1000 THIRD GENERATION PSA CALIBRATION VERIFICATION MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Garo Mimaryan |
| Correspondent | Garo Mimaryan Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. 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 | 2012-08-20 |
| Decision Date | 2013-03-14 |
| Summary: | summary |