Submission Details
| 510(k) Number | K954996 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 01, 1995 |
| Decision Date | August 08, 1996 |
| Days to Decision | 281 days |
| Submission Type | Traditional |
| Review Panel | Microbiology (MI) |
| Summary | Summary PDF |
Cleared
Traditional
TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM
Aug 1996
Decision
281d
Days
Class 2
Risk
About This 510(k) Submission
K954996 is an FDA 510(k) clearance for the TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEM, a Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. (Class II — Special Controls, product code KHW), submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on August 8, 1996, 281 days after receiving the submission on November 1, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.
Device Classification
| Product Code | KHW — Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp. |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 866.3220 |
Manufacturer
Similar Devices — KHW Antigen, Id, Ha, Cep, Entamoeba Histolytica & Rel. Spp.
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