IMMULITE® 2000 Cortisol
Radioimmunoassay, Cortisol
Siemens Healthcare Diagnostics Products Ltd.
The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Ltd. with the FDA for Immulite® 2000 Cortisol.
Pre-market Notification Details
| Device ID | K202826 |
| 510k Number | K202826 |
| Device Name: | IMMULITE® 2000 Cortisol |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | Siemens Healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis Caernarfon, GB Ll55 4el |
| Contact | Malgorzata Robak |
| Correspondent | Malgorzata Robak Siemens Healthcare Diagnostics Products Ltd. Glyn Rhonwy, Llanberis Caernarfon, GB Ll55 4el |
| Product Code | CGR |
| CFR Regulation Number | 862.1205 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-09-24 |
| Decision Date | 2021-01-15 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414167411 | K202826 | 000 |
| 00630414167404 | K202826 | 000 |
Trademark Results [IMMULITE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 IMMULITE 74098401 1653588 Live/Registered |
SIEMENS HEALTHCARE DIAGNOSTICS INC. 1990-09-19 |
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