ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit— 510(k) DEN160025

Name: FDA 510(k) clearance DEN160025
Creator: U.S. Food and Drug Administration
Published: 2017-08-18

Unknown

Id-Fish Technology, Inc.

FDA 510(k) clearance DEN160025 for ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit, Unknown on 2017-08-18. Applicant: Id-Fish Technology, Inc.. Device class: 2.

Clearance details

Applicant: Id-Fish Technology, Inc.
Product code: Code PYN
Device class: Class 2
Regulation: 21 CFR 866.3367
Advisory panel: Microbiology
Date received: 2016-06-27
Decision date: 2017-08-18
Decision: Unknown
Clearance type: Direct
Location: Palo Alto, CA, US

View on FDA.gov ↗

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