A.Qc Chemistry Control Level 2

Q: What is the product code of K883012?

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

FDA 510(k) K883012 · Arden Medical Systems, Inc.

Substantially Equivalent

510(k) numberK883012

Submission

Device name: A.Qc Chemistry Control Level 2
Applicant: Arden Medical Systems, Inc.
Roseville, MN, US
Received: July 19, 1988
Decision date: September 9, 1988
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.

510(k)	Device	Decision
K873611	A-Qc Clinical Chemistry ControlJJY · Traditional	10/20/1987SE
K870860	Chempro 1000(TM)GKF · Traditional	04/14/1987SE

Questions and answers

When was A.Qc Chemistry Control Level 2 cleared by the FDA?

A.Qc Chemistry Control Level 2 (K883012) received a 510(k) decision of Substantially Equivalent on September 9, 1988, 52 days after the submission was received.

What is the product code of K883012?

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