The following data is part of a premarket notification filed by Remel, L.p. with the FDA for Remel Bile Esculin Azide Agar W/6 Mcg/ml Vancomycin.
| Device ID | K972359 |
| 510k Number | K972359 |
| Device Name: | REMEL BILE ESCULIN AZIDE AGAR W/6 MCG/ML VANCOMYCIN |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Contact | Mary Ann Silvius |
| Correspondent | Mary Ann Silvius REMEL, L.P. 12076 SANTA FE DR. Lenexa, KS 66215 -3594 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-06-25 |
| Decision Date | 1997-08-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00848838093333 | K972359 | 000 |
| 00848838000546 | K972359 | 000 |