The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Remel Spectra Mrsa.
| Device ID | K092407 |
| 510k Number | K092407 |
| Device Name: | REMEL SPECTRA MRSA |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL, INC. 12076 SANTA FE DR. 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 | 2009-08-06 |
| Decision Date | 2010-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838097454 | K092407 | 000 |
| 00848838069826 | K092407 | 000 |
| 00848838069819 | K092407 | 000 |