The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Cedia Mycophenolic Acid Assay, Calibrators, Mas Mycophenolic Acid Controls.
| Device ID | K081083 |
| 510k Number | K081083 |
| Device Name: | CEDIA MYCOPHENOLIC ACID ASSAY, CALIBRATORS, MAS MYCOPHENOLIC ACID CONTROLS |
| Classification | Mycophenolic Acid Test System |
| Applicant | Thermo Fisher Scientific 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers Thermo Fisher Scientific 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | OAV |
| Subsequent Product Code | DLJ |
| Subsequent Product Code | LAS |
| CFR Regulation Number | 862.3840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-16 |
| Decision Date | 2008-12-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011878 | K081083 | 000 |
| 00884883001848 | K081083 | 000 |
| 00884883001831 | K081083 | 000 |
| 00884883001824 | K081083 | 000 |
| 00884883001817 | K081083 | 000 |
| 00884883001800 | K081083 | 000 |