The following data is part of a premarket notification filed by Siemens Helathcare Diagnostics Inc. with the FDA for Immulite 2000 Anti-tg Ab Calibration Verification Material, Immulite 2000 Anti-tpo Ab Calibration Verificatin Material.
| Device ID | K132391 |
| 510k Number | K132391 |
| Device Name: | IMMULITE 2000 ANTI-TG AB CALIBRATION VERIFICATION MATERIAL, IMMULITE 2000 ANTI-TPO AB CALIBRATION VERIFICATIN MATERIAL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | SIEMENS HELATHCARE DIAGNOSTICS INC. 511 Benedict Avenue Tarrytown, NY 10591 |
| Contact | Garo Mimaryan |
| Correspondent | Garo Mimaryan SIEMENS HELATHCARE DIAGNOSTICS INC. 511 Benedict Avenue 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 | 2013-08-01 |
| Decision Date | 2013-09-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414979472 | K132391 | 000 |
| 00630414971407 | K132391 | 000 |
| 00630414971384 | K132391 | 000 |