The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulte 2000 Rubella Quantitative Igg Calibration Verification Material.
| Device ID | K141772 |
| 510k Number | K141772 |
| Device Name: | IMMULTE 2000 RUBELLA QUANTITATIVE IGG CALIBRATION VERIFICATION MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Asha Gartland |
| Correspondent | Asha Gartland Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. 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 | 2014-07-01 |
| Decision Date | 2014-08-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414973784 | K141772 | 000 |
| 00630414973678 | K141772 | 000 |
| 00630414971414 | K141772 | 000 |