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 |