K143639 is an FDA 510(k) clearance for the IMMULITE 2000 CEA Calibration Verification Material. This device is classified as a Single (specified) Analyte Controls (assayed And Unassayed) (Class I - General Controls, product code JJX).
Submitted by Siemens Healthcare Diagnostics (Tarrytown, US). The FDA issued a Cleared decision on January 23, 2015, 32 days after receiving the submission on December 22, 2014.
This device falls under the Immunology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K143639 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2014 |
| Decision Date | January 23, 2015 |
| Days to Decision | 32 days |
| Submission Type | Abbreviated |
| Review Panel | Immunology (IM) |
| Summary | Summary PDF |
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 862.1660 |