Hemaprompt

FDA 510(k) K972763 · Aerscher Diagnostics

Substantially Equivalent

510(k) numberK972763

Submission

Device name
Hemaprompt
Applicant
Aerscher Diagnostics
Chestertown, MD, US
Received
July 24, 1997
Decision date
October 20, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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

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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
K031356Hemaprompt GastricKHE · Traditional 09/24/2003SE
K981661HemapromptKHE · Traditional 09/15/1998SE

Questions and answers

When was Hemaprompt cleared by the FDA?

Hemaprompt (K972763) received a 510(k) decision of Substantially Equivalent on October 20, 1997, 88 days after the submission was received.

What is the product code of K972763?

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