510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163554Substantially Equivalent

hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test

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

K163554 is the FDA 510(k) clearance record for hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test, a class II device, cleared for Immunostics Inc., on under FDA product code KHE (Reagent, Occult Blood). FDA records list 25 510(k) clearances for Immunostics Inc.,, from to . As of , FDA records show no recalls naming K163554.

Clearance record

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

Clearances, product code KHE

Trailing 12 months

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

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