K873299 is an FDA 510(k) clearance for the MERIFLUOR(TM)-GIARDIA. This device is classified as a Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp (Class II - Special Controls, product code GWD).
Submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on September 16, 1987, 29 days after receiving the submission on August 18, 1987.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.
| 510(k) Number | K873299 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 18, 1987 |
| Decision Date | September 16, 1987 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | — |
| Product Code | GWD — Indirect Fluorescent Antibody Test, Entamoeba Histolytica & Rel Sp |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3220 |