Medical Device Manufacturer · US , Ocean , NJ

Immunostics Inc.,

14 submissions · 14 cleared · Since 1997
14
Total
14
Cleared
0
Denied

Immunostics Inc., — FDA 510(k) Submissions

Immunostics Inc., has submitted 14 FDA 510(k) premarket notifications since 1997, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Reagent, Occult Blood, System, Hemoglobin, Automated, System, Test, Vitamin D, System, Test, Rheumatoid Factor, System, Test, Infectious Mononucleosis . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
ALFIS Vitamin D, ALFIS-3 Analyzer
K221817 · MRG System, Test, Vitamin D · Chemistry
Sep 2023 457d
hemochroma PLUS System
K182298 · GKR System, Hemoglobin,... · Hematology
Nov 2018 84d
hemochroma PLUS System
K163465 · GKR System, Hemoglobin,... · Hematology
Sep 2017 270d
AFIAS iFOB with AFIAS-50
K163225 · OOX Automated Occult Blood... · Hematology
Aug 2017 264d
hema-screen SPECIFIC Gold
K171484 · KHE Reagent, Occult Blood · Hematology
Jun 2017 23d
hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test
K163554 · KHE Reagent, Occult Blood · Hematology
Jan 2017 29d
HEMA SCREEN ER
K102664 · KHE Reagent, Occult Blood · Hematology
Jan 2011 135d
HEMA SCREEN SPECIFIC IFOBT
K060463 · KHE Reagent, Occult Blood · Hematology
Jun 2006 104d
HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE
K041728 · JHI Visual, Pregnancy Hcg,... · Chemistry
Aug 2004 47d
RUBELLACOL
K031490 · LQN Latex Agglutination... · Microbiology
Jul 2003 65d
COLON ALERT TEST
K992759 · KHE Reagent, Occult Blood · Hematology
Dec 1999 111d
MONOCOL/LEX-IM TEST
K972457 · KTN System, Test, Infectious... · Immunology
Dec 1997 153d
RHEUMACOL RHEUMATOID FACTOR TEST
K972456 · DHR System, Test, Rheumatoid... · Immunology
Nov 1997 147d
PREGNACOL PREGNANCY TEST
K972606 · JHJ Agglutination Method,... · Chemistry
Aug 1997 49d
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