The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Emit 2000 Sirolimus Assay, Emit 2000 Siro/tacro Sample Pretreatment Reagent, And Emit 200 Sirolimus Calibrator.
| Device ID | K083487 |
| 510k Number | K083487 |
| Device Name: | EMIT 2000 SIROLIMUS ASSAY, EMIT 2000 SIRO/TACRO SAMPLE PRETREATMENT REAGENT, AND EMIT 200 SIROLIMUS CALIBRATOR |
| Classification | Sirolimus Test System |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Contact | Yuk-ting Lewis |
| Correspondent | Yuk-ting Lewis SIEMENS HEALTHCARE DIAGNOSTICS MS 514, PO BOX 6101 Newark, DE 19714 -6101 |
| Product Code | NRP |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-25 |
| Decision Date | 2009-03-30 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768030048 | K083487 | 000 |
| 00842768029622 | K083487 | 000 |
| 00842768029615 | K083487 | 000 |