Submission Details
| 510(k) Number | K143639 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Abbreviated
IMMULITE 2000 CEA Calibration Verification Material
Jan 2015
Decision
32d
Days
Class 1
Risk
About This 510(k) Submission
K143639 is an FDA 510(k) clearance for the IMMULITE 2000 CEA Calibration Verification Material, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Siemens Healthcare Diagnostics (New York, 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 review panel. Regulated under 21 CFR 862.1660.
Device Classification
| Product Code | JJX — Single (specified) Analyte Controls (assayed And Unassayed) |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1660 |
Manufacturer
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