The following data is part of a premarket notification filed by Waters Corporation with the FDA for Masstrak Immunosuppressants Kit.
| Device ID | K063868 |
| 510k Number | K063868 |
| Device Name: | MASSTRAK IMMUNOSUPPRESSANTS KIT |
| Classification | Enzyme Immunoassay, Tracrolimus |
| Applicant | WATERS CORPORATION 163 CABOT STREET Beverly, MA 01915 |
| Contact | Fran White |
| Correspondent | Fran White WATERS CORPORATION 163 CABOT STREET Beverly, MA 01915 |
| Product Code | MLM |
| Subsequent Product Code | JIT |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1678 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-29 |
| Decision Date | 2007-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816776020001 | K063868 | 000 |