The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Microgenics Cyclosporine Control Kit.
| Device ID | K032842 |
| 510k Number | K032842 |
| Device Name: | MICROGENICS CYCLOSPORINE CONTROL KIT |
| Classification | Drug Specific Control Materials |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | David Casal |
| Correspondent | David Casal 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 | 2003-09-11 |
| Decision Date | 2003-10-17 |
| Summary: | summary |