The following data is part of a premarket notification filed by Merck, Sharp & Dohme with the FDA for Imipenem Susceptibility Powder.
Device ID | K855071 |
510k Number | K855071 |
Device Name: | IMIPENEM SUSCEPTIBILITY POWDER |
Classification | Susceptibility Test Powders, Antimicrobial |
Applicant | MERCK, SHARP & DOHME DIVISION OF MERCK & CO., INC. West Point, PA 19486 |
Contact | David W Blois |
Correspondent | David W Blois MERCK, SHARP & DOHME DIVISION OF MERCK & CO., INC. West Point, PA 19486 |
Product Code | JTT |
CFR Regulation Number | 866.1640 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-12-19 |
Decision Date | 1986-03-06 |