The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Immunocard(tm) C. Difficile.
Device ID | K924979 |
510k Number | K924979 |
Device Name: | IMMUNOCARD(TM) C. DIFFICILE |
Classification | Reagents, Clostridium Difficile Toxin |
Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Contact | Allen D Nickol |
Correspondent | Allen D Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Product Code | LLH |
CFR Regulation Number | 866.2660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-10-01 |
Decision Date | 1993-01-26 |