The following data is part of a premarket notification filed by Meridian Diagnostics, Inc. with the FDA for Merifluor(tm)-giardia.
| Device ID | K873299 |
| 510k Number | K873299 |
| Device Name: | MERIFLUOR(TM)-GIARDIA |
| Classification | Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| 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 | GWD |
| CFR Regulation Number | 866.3220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-08-18 |
| Decision Date | 1987-09-16 |