The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Mas Immunosuppressant Controls.
| Device ID | K051074 |
| 510k Number | K051074 |
| Device Name: | MAS IMMUNOSUPPRESSANT CONTROLS |
| Classification | Drug Specific Control Materials |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-27 |
| Decision Date | 2005-06-06 |
| Summary: | summary |