The following data is part of a premarket notification filed by Microgenics Corp. with the FDA for Microgenics Thc Control Sets.
| Device ID | K943048 |
| 510k Number | K943048 |
| Device Name: | MICROGENICS THC CONTROL SETS |
| Classification | Drug Specific Control Materials |
| Applicant | MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Contact | Betsy Maddox |
| Correspondent | Betsy Maddox MICROGENICS CORP. 2380A BISSO LN. Concord, CA 94520 |
| Product Code | LAS |
| CFR Regulation Number | 862.3280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-27 |
| Decision Date | 1994-08-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884883004870 | K943048 | 000 |
| 00884883004863 | K943048 | 000 |
| 00884883001954 | K943048 | 000 |