The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000; Total T3 Calibration Verification Material, Total T4 Calibration Verification Material, Total Tbg Calibra.
| Device ID | K133124 |
| 510k Number | K133124 |
| Device Name: | IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Siemens Healthcare Diagnostics Inc. 511 BENEDICT AVE. Tarrytown, NY 10591 |
| Contact | Garo Mimaryan |
| Correspondent | Garo Mimaryan 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 | 2013-09-30 |
| Decision Date | 2013-10-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414973807 | K133124 | 000 |
| 00630414973623 | K133124 | 000 |
| 00630414971377 | K133124 | 000 |
| 00630414971360 | K133124 | 000 |
| 00630414971216 | K133124 | 000 |