510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN160025Unknown

ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit

ID-Fish Technology, Inc, Palo Alto CA / Direct, Unknown
FDA source (opens on fda.gov)

DEN160025 is the FDA 510(k) clearance record for ID-FISH Plasmodium Genus Test Kit, ID-FISH Plasmodium falciparum and P. vivax Combo Test Kit, a class II device, cleared for Id-Fish Technology, Inc. on under FDA product code PYN (Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.). FDA's definition for product code PYN reads: "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". FDA records list 3 510(k) clearances for Id-Fish Technology, Inc., from to . As of , FDA records show no recalls naming DEN160025.

Clearance record

Decision date
Received
(417 days to decision)
Product code
PYN Fish (Fluorescence In Situ Hybridization) Kit, Nucleic Acid, Plasmodium Sp.
Regulation
21 CFR 866.3367
Device class
Class II
Review panel
Microbiology
Applicant
Id-Fish Technology, Inc. 797 San Antonio Rd., Palo Alto CA
Third party review
No

Clearances, product code PYN

Trailing 12 months

FDA records hold no clearances under product code PYN in the trailing twelve months.

FDA records show no clearances under product code PYN in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PYN, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260