The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Cyclosporine Plus High Range Controls 4 And 5.
| Device ID | K030616 |
| 510k Number | K030616 |
| Device Name: | CEDIA CYCLOSPORINE PLUS HIGH RANGE CONTROLS 4 AND 5 |
| Classification | Drug Specific Control Materials |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Rueyming Loor |
| Correspondent | Rueyming Loor 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 | 2003-02-26 |
| Decision Date | 2003-03-31 |