The following data is part of a premarket notification filed by Siemens Heatlhcare Diagnostics Inc with the FDA for Dimension Mycophenolic Acid (mpat) Flex Reagent Cartridge, Dimension Mycophenolic Acid Calibrator (mpat Cal).
| Device ID | K102772 |
| 510k Number | K102772 |
| Device Name: | DIMENSION MYCOPHENOLIC ACID (MPAT) FLEX REAGENT CARTRIDGE, DIMENSION MYCOPHENOLIC ACID CALIBRATOR (MPAT CAL) |
| Classification | Mycophenolic Acid Test System |
| Applicant | SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE M/S 514 Newark, DE 19714 -6101 |
| Contact | Helen M Lee |
| Correspondent | Helen M Lee SIEMENS HEATLHCARE DIAGNOSTICS INC 500 GBC DRIVE M/S 514 Newark, DE 19714 -6101 |
| Product Code | OAV |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-24 |
| Decision Date | 2011-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842768036217 | K102772 | 000 |
| 00842768004902 | K102772 | 000 |