The following data is part of a premarket notification filed by Biomerieux, Inc. with the FDA for Gram Postitve Clindamycin.
Device ID | K122547 |
510k Number | K122547 |
Device Name: | GRAM POSTITVE CLINDAMYCIN |
Classification | System, Test, Automated, Antimicrobial Susceptibility, Short Incubation |
Applicant | BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
Contact | Elizabeth Landon |
Correspondent | Elizabeth Landon BIOMERIEUX, INC. 595 ANGLUM RD. Hazelwood, MO 63042 |
Product Code | LON |
CFR Regulation Number | 866.1645 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-21 |
Decision Date | 2012-10-15 |
Summary: | summary |