The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Cedia Cyclosporine Plus Assay.
| Device ID | K023208 |
| 510k Number | K023208 |
| Device Name: | CEDIA CYCLOSPORINE PLUS ASSAY |
| Classification | Cyclosporine |
| Applicant | MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Mark Hamilton Smith |
| Correspondent | Mark Hamilton Smith MICROGENICS CORP. 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | MKW |
| CFR Regulation Number | 862.1235 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2002-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883011861 | K023208 | 000 |
| 00884883001589 | K023208 | 000 |
| 00884883001299 | K023208 | 000 |