510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K102664Substantially Equivalent

Hema Screen Er

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

K102664 is the FDA 510(k) clearance record for HEMA SCREEN ER, 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 K102664.

Clearance record

Decision date
Received
(135 days to decision)
Product code
KHE Reagent, Occult Blood
Regulation
21 CFR 864.6550
Device class
Class II
Review panel
Hematology
Applicant
Immunostics Inc., 3505 Sunset Ave., Ocean NJ
510(k) summary
Statement
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