The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Merifluor Tm Pneumocystis Modification.
Device ID | K904400 |
510k Number | K904400 |
Device Name: | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION |
Classification | Pneumocystis Carinii |
Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Contact | Allen Nickol |
Correspondent | Allen Nickol MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
Product Code | LYF |
CFR Regulation Number | 866.3780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-09-21 |
Decision Date | 1990-10-16 |