Dia Screen 10 Way Reagent Strips

FDA 510(k) K961375 · Genesis Labs, Inc.

Substantially Equivalent

510(k) numberK961375

Submission

Device name
Dia Screen 10 Way Reagent Strips
Applicant
Genesis Labs, Inc.
Minneapolis, MN, US
Received
April 9, 1996
Decision date
June 18, 1996
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

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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Questions and answers

When was Dia Screen 10 Way Reagent Strips cleared by the FDA?

Dia Screen 10 Way Reagent Strips (K961375) received a 510(k) decision of Substantially Equivalent on June 18, 1996, 70 days after the submission was received.

What is the product code of K961375?

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