Cleared Traditional

PROSTATE SPECIFIC ANTIGEN CONTROL

K973099 · Dade Chemistry Systems, Inc. · Immunology
Sep 1997
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K973099 is an FDA 510(k) clearance for the PROSTATE SPECIFIC ANTIGEN CONTROL, a Single (specified) Analyte Controls (assayed And Unassayed) (Class I — General Controls, product code JJX), submitted by Dade Chemistry Systems, Inc. (Newark, US). The FDA issued a Cleared decision on September 29, 1997, 41 days after receiving the submission on August 19, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K973099 FDA.gov
FDA Decision Cleared SESE
Date Received August 19, 1997
Decision Date September 29, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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