Cleared Traditional

PROSTAT CONTROL

K943394 · Quantimetrix Corp. · Immunology
May 1995
Decision
313d
Days
Class 1
Risk

About This 510(k) Submission

K943394 is an FDA 510(k) clearance for the PROSTAT CONTROL, a Multi-analyte Controls, All Kinds (assayed) (Class I — General Controls, product code JJY), submitted by Quantimetrix Corp. (Hawthorne, US). The FDA issued a Cleared decision on May 23, 1995, 313 days after receiving the submission on July 14, 1994. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K943394 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 1994
Decision Date May 23, 1995
Days to Decision 313 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code JJY — Multi-analyte Controls, All Kinds (assayed)
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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