Hema-Screen

FDA 510(k) K902360 · Immunostics Co., Inc.

Substantially Equivalent

510(k) numberK902360

Submission

Device name
Hema-Screen
Applicant
Immunostics Co., Inc.
Ocean, NJ, US
Received
May 29, 1990
Decision date
July 27, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KHE – Reagent, Occult Blood
Device class
Class II (moderate risk)
Regulation
21 CFR 864.6550
Specialty
Hematology

Other 510(k)s with product code KHE

510(k)DeviceApplicantDecision
K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional Alfa Scientific Designs, Inc.02/15/2018SE
K170548InSure ONEKHE · Traditional Enterix, Inc.10/05/2017SE
K171484hema-screen SPECIFIC GoldKHE · Special Immunostics Inc.,06/14/2017SE
K162333Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional Guangzhou Wondfo Biotech Co., Ltd.05/14/2017SE
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special Immunostics Inc.,01/17/2017SE
K143325OC-Light S FITKHE · Traditional Eiken Chemical Co., Ltd.08/20/2015SE
K121397Osom Ifob 25 Test and Patient Collection Kit Osom Ifob Control Kit Osom Ifob 50 Test KitKHE · Traditional SEKISUI Diagnostics, LLC12/28/2012SE
K113506Ind One Step Occult Blood (Fob) TestKHE · Special Ind Diagnostics, Inc.12/19/2012SE
K110309Fob One Step Rapid TestKHE · Traditional Orient Gene Biotech09/14/2011SE
K102664Hema Screen ErKHE · Special Immunostics Inc.,01/28/2011SE

More from Immunostics Inc.,

510(k)DeviceDecision
K221817ALFIS Vitamin D, ALFIS-3 AnalyzerMRG · Traditional 09/22/2023SE
K182298hemochroma PLUS SystemGKR · Traditional 11/16/2018SE
K163465hemochroma PLUS SystemGKR · Traditional 09/08/2017SE
K163225AFIAS iFOB with AFIAS-50OOX · Traditional 08/08/2017SE
K171484hema-screen SPECIFIC GoldKHE · Special 06/14/2017SE
K163554hema-screen ER XCEL Enhanced Readability Fecal Occult Blood TestKHE · Special 01/17/2017SE
K102664Hema Screen ErKHE · Special 01/28/2011SE
K060463Hema Screen Specific IfobtKHE · Traditional 06/06/2006SE
K041728HCG Detector Combi, HCG Detector Stix, HCG Detector CassetteJHI · Traditional 08/11/2004SE
K031490RubellacolLQN · Traditional 07/16/2003SE

Questions and answers

When was Hema-Screen cleared by the FDA?

Hema-Screen (K902360) received a 510(k) decision of Substantially Equivalent on July 27, 1990, 59 days after the submission was received.

What is the product code of K902360?

The FDA product code is KHE – Reagent, Occult Blood, a Class II (moderate risk) device regulated under 21 CFR 864.6550.