Who is the manufacturer of CHEMISTRY CONSOLE?

Biovation, Inc. filed the 510(k) submission for CHEMISTRY CONSOLE (K842401).

What is the FDA product code for CHEMISTRY CONSOLE?

JQP. It is classified under 21 CFR 862.2100 as a Class 1 device in the Clinical Chemistry panel.

What is the regulatory pathway for CHEMISTRY CONSOLE?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like CHEMISTRY CONSOLE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

CHEMISTRY CONSOLE

K842401 · Biovation, Inc. · JQP · Sep 4, 1984 · Clinical Chemistry

Device Facts

Record ID	K842401
Device Name	CHEMISTRY CONSOLE
Applicant	Biovation, Inc.
Product Code	JQP · Clinical Chemistry
Decision Date	Sep 4, 1984
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 862.2100
Device Class	Class 1

Regulatory Classification

Identification

A calculator/data processing module for clinical use is an electronic device intended to process laboratory data.

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CHEMISTRY CONSOLE

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CHEMISTRY CONSOLE

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