510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K161364Substantially Equivalent

BinaxNOW G6PD Test

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

K161364 is the FDA 510(k) clearance record for BinaxNOW G6PD Test, a class II device, cleared for Alere Scarborough, Inc. on under FDA product code JBF (Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening). FDA records list 17 510(k) clearances for Alere Scarborough, Inc., from to . As of , FDA records show no recalls naming K161364.

Clearance record

Decision date
Received
(31 days to decision)
Product code
JBF Glucose-6-Phosphate Dehydrogenase (Erythrocytic), Screening
Regulation
21 CFR 864.7360
Device class
Class II
Review panel
Hematology
Applicant
Alere Scarborough, Inc. 10 Southgate Rd., Scarborough ME
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JBF

Trailing 12 months

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

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