The following data is part of a premarket notification filed by More Diagnostics with the FDA for Mycophenolic Acid Control, Level 1, 2, 3, 4, 4-level.
| Device ID | K072257 |
| 510k Number | K072257 |
| Device Name: | MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVEL |
| Classification | Drug Specific Control Materials |
| Applicant | MORE DIAGNOSTICS 2020 11TH ST. Los Osos, CA 93402 |
| Contact | James W Snipes |
| Correspondent | James W Snipes MORE DIAGNOSTICS 2020 11TH ST. Los Osos, CA 93402 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-08-13 |
| Decision Date | 2008-01-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00856743007109 | K072257 | 000 |
| 00856743007093 | K072257 | 000 |
| 00856743007086 | K072257 | 000 |
| 00856743007079 | K072257 | 000 |
| 00856743007062 | K072257 | 000 |