A-Qc Clinical Chemistry Control

FDA 510(k) K873611 · Arden Medical Systems, Inc.

Substantially Equivalent

510(k) numberK873611

Submission

Device name
A-Qc Clinical Chemistry Control
Applicant
Arden Medical Systems, Inc.
Roseville, MN, US
Received
September 8, 1987
Decision date
October 20, 1987
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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K883012A.Qc Chemistry Control Level 2JJY · Traditional 09/09/1988SE
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Questions and answers

When was A-Qc Clinical Chemistry Control cleared by the FDA?

A-Qc Clinical Chemistry Control (K873611) received a 510(k) decision of Substantially Equivalent on October 20, 1987, 42 days after the submission was received.

What is the product code of K873611?

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