510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163465Substantially Equivalent

hemochroma PLUS System

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

K163465 is the FDA 510(k) clearance record for hemochroma PLUS System, a class II device, cleared for Immunostics Inc., on under FDA product code GKR (System, Hemoglobin, Automated). FDA records list 25 510(k) clearances for Immunostics Inc.,, from to . As of , FDA records show no recalls naming K163465.

Clearance record

Decision date
Received
(270 days to decision)
Product code
GKR System, Hemoglobin, Automated
Regulation
21 CFR 864.5620
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 GKR

Trailing 12 months

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

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