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 |