The following data is part of a premarket notification filed by Acumedia Manufacturers, Inc. with the FDA for Wilkens Chalgren Agar.
Device ID | K881567 |
510k Number | K881567 |
Device Name: | WILKENS CHALGREN AGAR |
Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
Applicant | ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
Contact | Cunningham, Phd |
Correspondent | Cunningham, Phd ACUMEDIA MANUFACTURERS, INC. 3651 CLIPPER MILL RD. Baltimore, MD 21211 |
Product Code | JSO |
CFR Regulation Number | 866.1700 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-04-11 |
Decision Date | 1988-04-18 |