Cleared Traditional

CHLAMYDIA OVERBY MEDIA

K831686 · Viromed Laboratories, Inc. · Pathology
Jul 1983
Decision
44d
Days
Class 1
Risk

About This 510(k) Submission

K831686 is an FDA 510(k) clearance for the CHLAMYDIA OVERBY MEDIA, a Media And Components, Synthetic Cell And Tissue Culture (Class I — General Controls, product code KIT), submitted by Viromed Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 7, 1983, 44 days after receiving the submission on May 24, 1983. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2220.

Submission Details

510(k) Number K831686 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1983
Decision Date July 07, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary —

Device Classification

Product Code KIT — Media And Components, Synthetic Cell And Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2220