510(k) DEN160025
- Device
- ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit
- Applicant
- Id-Fish Technology, Inc.
- 510(k) number
- DEN160025
- Product code
- PYN
- Decision
- Unknown (DENG)
- Decision date
- 2017-08-18
- Date received
- 2016-06-27
- Regulation
- 866.3367
- Classification name
- Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- JYOTSNA SHAH
- Address
- 797 San Antonio Rd. Palo Alto CA US 94303 94303
Source Documents#
510(k) summary PDF not indicated by FDA