The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Merifluor(tm) Pneumocystis.
| Device ID | K881608 |
| 510k Number | K881608 |
| Device Name: | MERIFLUOR(TM) PNEUMOCYSTIS |
| Classification | Pneumocystis Carinii |
| Applicant | MERIDIAN DIAGNOSTICS, INC. 3471 RIVER HILLS DR. Cincinnati, OH 45244 |
| Contact | Bruce A Clinton,phd |
| Correspondent | Bruce A Clinton,phd 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 | 1988-04-12 |
| Decision Date | 1988-08-04 |