The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Mgc Dau Control Sets: Primary, Clinical And Select.
| Device ID | K040758 |
| 510k Number | K040758 |
| Device Name: | MGC DAU CONTROL SETS: PRIMARY, CLINICAL AND SELECT |
| Classification | Drug Mixture 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 | DIF |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-03-25 |
| Decision Date | 2004-05-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740007744 | K040758 | 000 |
| 00380740005818 | K040758 | 000 |
| 00380740005740 | K040758 | 000 |
| 00884883001633 | K040758 | 000 |
| 00884883001626 | K040758 | 000 |
| 00884883001619 | K040758 | 000 |
| 00630414550916 | K040758 | 000 |
| 00630414002699 | K040758 | 000 |