Combi SCAN100

FDA 510(k) K061846 · Analyticon Biotechnologies AG

Substantially Equivalent

510(k) numberK061846

Submission

Device name
Combi SCAN100
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

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More from Teco Diagnostics

510(k)DeviceDecision
K061812Combi Scan 500 Urine Test Strip Analyzer, Model A93005JIL · Traditional 04/06/2007SE
K023885Combi-Screen, Models 10SL and 11SLJIL · Traditional 10/21/2003SE

Questions and answers

When was Combi SCAN100 cleared by the FDA?

Combi SCAN100 (K061846) 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 K061846?

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