K141772 is an FDA 510(k) clearance for the IMMULTE 2000 RUBELLA QUANTITATIVE IGG 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, Inc. (Tarrytown, US). The FDA issued a Cleared decision on August 19, 2014, 49 days after receiving the submission on July 1, 2014.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.1660.
| 510(k) Number | K141772 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 01, 2014 |
| Decision Date | August 19, 2014 |
| Days to Decision | 49 days |
| Submission Type | Abbreviated |
| Review Panel | Microbiology (MI) |
| 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 |