The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics with the FDA for Dimension Tacrolimus Flex® Reagent Cartridge (tac), Dimension Tacrolimus Calibrator (tac Cal).
| Device ID | K150168 |
| 510k Number | K150168 |
| Device Name: | Dimension Tacrolimus Flex® Reagent Cartridge (TAC), Dimension Tacrolimus Calibrator (TAC CAL) |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark, DE 19714 |
| Contact | Anna Marie Kathleen Ennis |
| Correspondent | Kathleen Dray-lyons SIEMENS HEALTHCARE DIAGNOSTICS 500 GBC DRIVE Newark, DE 19714 |
| Product Code | MLM |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-26 |
| Decision Date | 2015-11-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768035432 | K150168 | 000 |
| 00842768035425 | K150168 | 000 |