Camco R Pak-Guaiac

FDA 510(k) K770153 · Cambridge Chemical Products, Inc.

Substantially Equivalent

510(k) numberK770153

Submission

Device name
Camco R Pak-Guaiac
Applicant
Cambridge Chemical Products, Inc.
Mchenry, IL, US
Received
January 24, 1977
Decision date
February 8, 1977
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

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K173212Instant-view-PLUS immunochemical Fecal Occult Blood TestKHE · Traditional Alfa Scientific Designs, Inc.02/15/2018SE
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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

More from Immunostics Inc.,

510(k)DeviceDecision
K860793Camco Stain PakIAF · Traditional 03/18/1986SE
K830223Fecal Occult Slide Test KitKHE · Traditional 03/07/1983SE
K781347Camco Quik Stain IIIAF · Traditional 08/21/1978SE

Questions and answers

When was Camco R Pak-Guaiac cleared by the FDA?

Camco R Pak-Guaiac (K770153) received a 510(k) decision of Substantially Equivalent on February 8, 1977, 15 days after the submission was received.

What is the product code of K770153?

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