The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Exl Loci Thyroid Calibrator, Model Rc 610a.
| Device ID | K100778 |
| 510k Number | K100778 |
| Device Name: | DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Rose T Marinelli |
| Correspondent | Rose T Marinelli SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-19 |
| Decision Date | 2010-05-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768031694 | K100778 | 000 |