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 |