510(k) DEN160025
DEN160025 is an FDA 510(k) premarket notification submitted by Id-Fish Technology, Inc. for the device "ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit". The FDA issued a decision of De Novo Granted on August 18, 2017. The device falls under product code PYN (Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.), a Class II device regulated under 21 CFR 866.3367. Id-Fish Technology, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 18, 2017
- Date Received
- June 27, 2016
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
- Device Class
- Class II
- Regulation Number
- 866.3367
- Review Panel
- MI
- Submission Type
The Plasmodium sp. FISH is intended to detect Plasmodium spp. parasites and/or differentiate parasite species in clinical whole blood smear specimens from patients with signs or symptoms of malaria and suspicion of infection.