The following data is part of a premarket notification filed by Microgenics Corporation with the FDA for Mas And Mini-trol Pth Control.
| Device ID | K092749 |
| 510k Number | K092749 |
| Device Name: | MAS AND MINI-TROL PTH CONTROL |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Lisa Charter |
| Correspondent | Lisa Charter Microgenics Corporation 46360 FREMONT BLVD. Fremont, CA 94538 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-08 |
| Decision Date | 2009-12-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004078 | K092749 | 000 |