The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Meritec(tm) - C. Difficile Latex Test System.
Device ID | K895915 |
510k Number | K895915 |
Device Name: | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM |
Classification | Antigen, C. Difficile |
Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Contact | Nickol, Phd |
Correspondent | Nickol, Phd MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Product Code | MCB |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-10-10 |
Decision Date | 1990-03-12 |