510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163225Substantially Equivalent

AFIAS iFOB with AFIAS-50

Immunostics, Inc., Ocean NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163225 is the FDA 510(k) clearance record for AFIAS iFOB with AFIAS-50, a class II device, cleared for Immunostics Inc., on under FDA product code OOX (Automated Occult Blood Analyzer). FDA's definition for product code OOX reads: "The automated test system is intended for the qualitative detection of fecal occult blood in feces by professional laboratories. The automated test is used for the determination of gastrointestinal bleeding". FDA records list 25 510(k) clearances for Immunostics Inc.,, from to . As of , FDA records show no recalls naming K163225.

Clearance record

Decision date
Received
(264 days to decision)
Product code
OOX Automated Occult Blood Analyzer
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Immunostics Inc., 1750 Brielle Ave. A5, Ocean NJ
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OOX

Trailing 12 months

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

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