510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K854314Substantially Equivalent

Fana 60

American Bio-Reagents, Inc., Easton PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854314 is the FDA 510(k) clearance record for FANA 60, a class II device, cleared for American Bio-Reagents, Inc. on under FDA product code DHN (Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control). FDA records list one 510(k) clearance for American Bio-Reagents, Inc. As of , FDA records show no recalls naming K854314.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DHN Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Regulation
21 CFR 866.5100
Device class
Class II
Review panel
Immunology
Applicant
American Bio-Reagents, Inc. 26 N. Fourth St., Easton PA
Third party review
No

Clearances, product code DHN

Trailing 12 months

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

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