510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083744Substantially Equivalent

Binaxnow Malaria Positive Control Kit, Model 665-010

Binax, Inc., Scarborough ME / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083744 is the FDA 510(k) clearance record for BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010, a class I device, cleared for Binax, Inc. on under FDA product code MJZ (Kit, Direct Antigen, Positive Control). FDA records list 9 510(k) clearances for Binax, Inc., from to . As of , FDA records show no recalls naming K083744.

Clearance record

Decision date
Received
(259 days to decision)
Product code
MJZ Kit, Direct Antigen, Positive Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Binax, Inc. 10 Southgate Rd., Scarborough ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MJZ

Trailing 12 months

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

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