Biotel (Tm)/ Kidney

FDA 510(k) K855237 · American Diagnostic Corp.

Substantially Equivalent

510(k) numberK855237

Submission

Device name
Biotel (Tm)/ Kidney
Applicant
American Diagnostic Corp.
Wheaton, IL, US
Received
December 31, 1985
Decision date
May 6, 1986
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

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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

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K940686Electronic ThermometersFLL · Traditional 07/08/1994SE
K935944Proscopes and AdscopesLDE · Traditional 03/03/1994SE
K932145Coagulation Reference Plasma, NormalGIZ · Traditional 10/18/1993SE
K894169Biotel Microalbuminuria (TM)JIR · Traditional 09/18/1989SE
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Questions and answers

When was Biotel (Tm)/ Kidney cleared by the FDA?

Biotel (Tm)/ Kidney (K855237) received a 510(k) decision of Substantially Equivalent on May 6, 1986, 126 days after the submission was received.

What is the product code of K855237?

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