The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000: C-peptide Calibration Verification Material, Shbg Calibration Verification Material, Total Testosterone C.
| Device ID | K140541 |
| 510k Number | K140541 |
| Device Name: | IMMULITE 2000: C-PEPTIDE CALIBRATION VERIFICATION MATERIAL, SHBG CALIBRATION VERIFICATION MATERIAL, TOTAL TESTOSTERONE C |
| 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 | 2014-03-04 |
| Decision Date | 2014-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414979465 | K140541 | 000 |
| 00630414978048 | K140541 | 000 |
| 00630414971339 | K140541 | 000 |