The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Mas Tox Control.
| Device ID | K080085 |
| 510k Number | K080085 |
| Device Name: | MAS TOX CONTROL |
| Classification | Drug Mixture Control Materials |
| Applicant | Thermo Fisher Scientific 46360 FREMONT BLVD. Fremont, CA 94538 |
| Contact | Jack Rogers |
| Correspondent | Jack Rogers Thermo Fisher Scientific 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 | 2008-01-11 |
| Decision Date | 2008-04-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740011321 | K080085 | 000 |
| 00884883003880 | K080085 | 000 |
| 00630414553733 | K080085 | 000 |