Cleared Traditional

SYSCOS IDC - G, IDC, BSC, IDC - G

K974262 · Scantibodies Laboratory, Inc. · Microbiology
Dec 1997
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K974262 is an FDA 510(k) clearance for the SYSCOS IDC - G, IDC, BSC, IDC - G, a Kit, Serological, Positive Control (Class I — General Controls, product code MJX), submitted by Scantibodies Laboratory, Inc. (Santee, US). The FDA issued a Cleared decision on December 24, 1997, 41 days after receiving the submission on November 13, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K974262 FDA.gov
FDA Decision Cleared SESE
Date Received November 13, 1997
Decision Date December 24, 1997
Days to Decision 41 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code MJX — Kit, Serological, Positive Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660

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