Cleared Traditional

LIQUISPEX URINE (MICRO)ALBUMIN CONTROL

K962432 · Clinical Controls, Inc. · Chemistry
Jul 1996
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K962432 is an FDA 510(k) clearance for the LIQUISPEX URINE (MICRO)ALBUMIN CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Clinical Controls, Inc. (Grover Beach, US). The FDA issued a Cleared decision on July 5, 1996, 11 days after receiving the submission on June 24, 1996. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K962432 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 1996
Decision Date July 05, 1996
Days to Decision 11 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JJX — Single (specified) Analyte Controls (assayed And Unassayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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