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 |