Ketone Test B Sanwa Standard

FDA 510(k) K903366 · Ihara Medics U.S., Inc.

Substantially Equivalent

510(k) numberK903366

Submission

Device name
Ketone Test B Sanwa Standard
Applicant
Ihara Medics U.S., Inc.
Valencia, CA, US
Received
July 26, 1990
Decision date
November 20, 1990
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JIN – Nitroprusside, Ketones (Urinary, Non-Quant.)
Device class
Class I (low risk)
Regulation
21 CFR 862.1435
Specialty
Clinical Chemistry

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K201551KetoSens BT Blood B-Ketone Monitoring SystemJIN · Special I-Sens, Inc.09/09/2020SE
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K182593KET-1 Blood Ketone Monitoring SystemJIN · Traditional Apex BioTechnology Corp.12/18/2018SE
K173345TD-4140 Smart Dongle Blood Glucose plus B-ketone Monitoring SystemJIN · Traditional Taidoc Technology Corporation05/04/2018SE
K170463KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring SystemJIN · Traditional I-Sens, Inc.04/13/2018SE
K170587On Call Ketone Reagent Strips for Urinalysis, Healthy Me Ketone Reagent Strips for…JIN · Traditional ACON Laboratories, Inc.07/06/2017SE
K060768Precision Xtra Blood B Ketone Test Strips, Optium Blood B Ketone Test StripsJIN · Special Abbott Diabetes Care, Inc.04/21/2006SE
K033114KetochecksJIN · Traditional Neo Diagnostics, Inc.04/26/2004SE
K003987URS-1K (Ketone Tesst)JIN · Traditional Teco Diagnostics04/26/2001SE
K953662First Choice Ketones Urine Test StripsJIN · Traditional Polymer Technology Intl.06/14/1996SE

More from Polymer Technology Intl.

510(k)DeviceDecision
K953452Ketorex C SanwaJMK · Traditional 05/02/1996SE
K912373KETO-340 IIJIN · Traditional 07/01/1991SE
K903365Ketorex Sanwa StandardsJIN · Traditional 12/20/1990SE
K903367Ketone Test a Sanwa StandardJIN · Traditional 11/20/1990SE

Questions and answers

When was Ketone Test B Sanwa Standard cleared by the FDA?

Ketone Test B Sanwa Standard (K903366) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 117 days after the submission was received.

What is the product code of K903366?

The FDA product code is JIN – Nitroprusside, Ketones (Urinary, Non-Quant.), a Class I (low risk) device regulated under 21 CFR 862.1435.