K133128 is an FDA 510(k) clearance for the IMMULITE 2000. 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, Inc. (Tarrytown, US). The FDA issued a Cleared decision on October 22, 2013, 22 days after receiving the submission on September 30, 2013.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K133128 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 30, 2013 |
| Decision Date | October 22, 2013 |
| Days to Decision | 22 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| 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 |