Cleared Traditional

QUALITROL SYPHSERO CONTROL SET

K961998 · Consolidated Technologies, Inc. · Microbiology
Aug 1996
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K961998 is an FDA 510(k) clearance for the QUALITROL SYPHSERO CONTROL SET, a Antisera, Control For Nontreponemal Tests (Class II — Special Controls, product code GMP), submitted by Consolidated Technologies, Inc. (Austin, US). The FDA issued a Cleared decision on August 8, 1996, 78 days after receiving the submission on May 22, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3820.

Submission Details

510(k) Number K961998 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1996
Decision Date August 08, 1996
Days to Decision 78 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GMP — Antisera, Control For Nontreponemal Tests
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3820

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