The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Products Ltd. with the FDA for Immulite/immulite® 1000 Cortisol.
| Device ID | K203270 |
| 510k Number | K203270 |
| Device Name: | IMMULITE/IMMULITE® 1000 Cortisol |
| Classification | Radioimmunoassay, Cortisol |
| Applicant | Siemens Healthcare Diagnostics Products Ltd. Glyn Rhonwy Llanberis, 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 | 2020-11-05 |
| Decision Date | 2021-01-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00630414963761 | K203270 | 000 |