Ars, Chemistry

FDA 510(k) K791313 · Mid Tech, Inc.

Substantially Equivalent

510(k) numberK791313

Submission

Device name
Ars, Chemistry
Applicant
Mid Tech, Inc.
Mchenry, IL, US
Received
July 12, 1979
Decision date
August 16, 1979
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JJY – Multi-Analyte Controls, All Kinds (Assayed)
Device class
Class I (low risk)
Regulation
21 CFR 862.1660
Specialty
Clinical Chemistry

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More from Aalto Scientific, Ltd.

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K810951Reagents for Quant. Enzymatic Deter.-Tr. · Traditional 04/23/1981SE
K791869Glucose Oxidase (Frinder) KitCGA · Traditional 10/01/1979SE
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Questions and answers

When was Ars, Chemistry cleared by the FDA?

Ars, Chemistry (K791313) received a 510(k) decision of Substantially Equivalent on August 16, 1979, 35 days after the submission was received.

What is the product code of K791313?

The FDA product code is JJY – Multi-Analyte Controls, All Kinds (Assayed), a Class I (low risk) device regulated under 21 CFR 862.1660.