The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Immulite 2000 Cea Calibration Verification Material.
| Device ID | K143639 |
| 510k Number | K143639 |
| Device Name: | IMMULITE 2000 CEA Calibration Verification Material |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Asha Gartland |
| Correspondent | Asha Gartland 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 | 2014-12-22 |
| Decision Date | 2015-01-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414971179 | K143639 | 000 |