Cleared Traditional

CHEMSPEX(TM) AMMONIA CONTROL

K946143 · Clinical Controls, Inc. · Chemistry
Feb 1995
Decision
49d
Days
Class 1
Risk

About This 510(k) Submission

K946143 is an FDA 510(k) clearance for the CHEMSPEX(TM) AMMONIA 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 February 3, 1995, 49 days after receiving the submission on December 16, 1994. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K946143 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 1994
Decision Date February 03, 1995
Days to Decision 49 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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