The following data is part of a premarket notification filed by Thermo Fisher Scientific with the FDA for Remel Spectra Vre.
| Device ID | K092819 |
| 510k Number | K092819 |
| Device Name: | REMEL SPECTRA VRE |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | Thermo Fisher Scientific 12150 SANTA FE DRIVE Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius Thermo Fisher Scientific 12150 SANTA FE DRIVE Lenexa, KS 66215 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-09-14 |
| Decision Date | 2010-07-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838079160 | K092819 | 000 |
| 00848838076824 | K092819 | 000 |