The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Immulite 2000; Hcg Calibration Verification Material, Insulin Calibration Verification Material, Pyrilinks-d Calibration.
| Device ID | K133128 |
| 510k Number | K133128 |
| Device Name: | IMMULITE 2000; HCG CALIBRATION VERIFICATION MATERIAL, INSULIN CALIBRATION VERIFICATION MATERIAL, PYRILINKS-D CALIBRATION |
| 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 | 2013-09-30 |
| Decision Date | 2013-10-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414973708 | K133128 | 000 |
| 00630414973661 | K133128 | 000 |
| 00630414973562 | K133128 | 000 |
| 00630414971322 | K133128 | 000 |
| 00630414000213 | K133128 | 000 |