K952467 is an FDA 510(k) clearance for the TREND GIARDIA LAMBLIA DIRECT DETECTION SYSTEM (MODIFIED KIT). This device is classified as a Giardia Spp. (Class II - Special Controls, product code MHI).
Submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on November 20, 1995, 178 days after receiving the submission on May 26, 1995.
This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3220.
| 510(k) Number | K952467 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 26, 1995 |
| Decision Date | November 20, 1995 |
| Days to Decision | 178 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
| Product Code | MHI — Giardia Spp. |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 866.3220 |