Combi Scan 500 Urine Test Strip Analyzer, Model A93005

Q: What is the product code of K061812?

The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.

FDA 510(k) K061812 · Analyticon Biotechnologies AG

Substantially Equivalent

510(k) numberK061812

Submission

Device name: Combi Scan 500 Urine Test Strip Analyzer, Model A93005
Applicant: Analyticon Biotechnologies AG
Lichtenfels, Hessen, DE
Received: June 26, 2006
Decision date: April 6, 2007
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)
Summary: 510(k) summary available from FDA
Third-party review: Yes

Official FDA 510(k) record

Device classification

Product code: JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
Device class: Class II (moderate risk)
Regulation: 21 CFR 862.1340
Specialty: Clinical Chemistry

Other 510(k)s with product code JIL

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K173327	DIP/U.S. Urine Analysis Test SystemJIL · Traditional	Healthy.Io, Ltd.	07/18/2018SE
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K171521	DUS R-50S (Urine Chemistry system)JIL · Traditional	DFI Co., Ltd.	02/16/2018SE
K171083	iChemVELOCITY Automated Urine Chemistry SystemJIL · Traditional	Iris Diagnostics, A Division of Iris…	05/12/2017SE
K160062	AUTION ELEVEN Semi-Automated Urinalysis SystemJIL · Traditional	Arkray, Inc.	10/07/2016SE
K160372	Uritek TC-201 Urine Chemistry Test SystemJIL · Traditional	Teco Diagnostics, Inc.	07/22/2016SE
K141289	Tc-Thunderbolt Automated Urine Analyzer System and Tc-Thunderbolt URS-10 StripsJIL · Traditional	Teco Diagnostics	07/24/2015SE

More from Teco Diagnostics

510(k)	Device	Decision
K061846	Combi SCAN100JIL · Traditional	04/06/2007SE
K023885	Combi-Screen, Models 10SL and 11SLJIL · Traditional	10/21/2003SE

Questions and answers

When was Combi Scan 500 Urine Test Strip Analyzer, Model A93005 cleared by the FDA?

Combi Scan 500 Urine Test Strip Analyzer, Model A93005 (K061812) received a 510(k) decision of Substantially Equivalent on April 6, 2007, 284 days after the submission was received.

What is the product code of K061812?

The FDA product code is JIL – Method, Enzymatic, Glucose (Urinary, Non-Quantitative), a Class II (moderate risk) device regulated under 21 CFR 862.1340.