Cleared Traditional

CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM

K961755 · Proteins Intl., Inc. · Microbiology
May 1996
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K961755 is an FDA 510(k) clearance for the CYTOQUANT CHLAMYDIA TRANSPORT MEDIUM, a Culture Media, Propagating Transport (Class I — General Controls, product code JSN), submitted by Proteins Intl., Inc. (Rochester Hills, US). The FDA issued a Cleared decision on May 17, 1996, 11 days after receiving the submission on May 6, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2390.

Submission Details

510(k) Number K961755 FDA.gov
FDA Decision Cleared SESE
Date Received May 06, 1996
Decision Date May 17, 1996
Days to Decision 11 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JSN — Culture Media, Propagating Transport
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2390

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