Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents

FDA 510(k) K022072 · Precision Systems, Inc.

Substantially Equivalent

510(k) numberK022072

Submission

Device name
Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents
Applicant
Precision Systems, Inc.
Natick, MA, US
Received
June 26, 2002
Decision date
August 23, 2002
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
CIX – Bromcresol Green Dye-Binding, Albumin
Device class
Class II (moderate risk)
Regulation
21 CFR 862.1035
Specialty
Clinical Chemistry

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Questions and answers

When was Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents cleared by the FDA?

Precision Systems Analette Chemistry Analyzer & Medical Analysis Systems Reagents (K022072) received a 510(k) decision of Substantially Equivalent on August 23, 2002, 58 days after the submission was received.

What is the product code of K022072?

The FDA product code is CIX – Bromcresol Green Dye-Binding, Albumin, a Class II (moderate risk) device regulated under 21 CFR 862.1035.