510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN070006Unknown

Binax Now Malaria Test; Model 660-000, 660-Xxx

Inverness Medical Professional Diagnostics-Binax, Scarborough ME / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN070006 is the FDA 510(k) clearance record for BINAX NOW MALARIA TEST; MODEL 660-000, 660-XXX, a class II device, cleared for Inverness Medical Professional Diagnostics-Binax on under FDA product code OAX (Plasmodium Spp. Detection Reagents). FDA's definition for product code OAX reads: "For the detection of plasmodium spp. Antigens in venous or capillary whole blood. To aid in the diagnosis of human malaria infections and/or to aid in the differential diagnosis of plasmodium falciparum infections from other less virulent...". FDA records list one 510(k) clearance for Inverness Medical Professional Diagnostics-Binax. As of , FDA records show no recalls naming DEN070006.

Clearance record

Decision date
Received
(82 days to decision)
Product code
OAX Plasmodium Spp. Detection Reagents
Regulation
21 CFR 866.3402
Device class
Class II
Review panel
Microbiology
Applicant
Inverness Medical Professional Diagnostics-Binax 10 Southgate Rd., Scarborough ME
Third party review
No

Clearances, product code OAX

Trailing 12 months

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

FDA records show no clearances under product code OAX in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code OAX, 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