The following data is part of a premarket notification filed by Remel, Inc. with the FDA for Rpmi 1640 Agar W/mops And 2% Glucose.
| Device ID | K072827 |
| 510k Number | K072827 |
| Device Name: | RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE |
| Classification | Culture Media, Antifungal, Susceptibility Test |
| Applicant | REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Contact | Andre Hsiung |
| Correspondent | Andre Hsiung REMEL, INC. 12076 SANTA FE DR. Lenexa, KS 66215 |
| Product Code | MJE |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-03 |
| Decision Date | 2007-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838004551 | K072827 | 000 |