Cleared Traditional

COLOR VUE TM- MYCOPLASMA PNEUMONIAE

K910833 · Seradyn, Inc. · Microbiology
Jun 1991
Decision
117d
Days
Class 1
Risk

About This 510(k) Submission

K910833 is an FDA 510(k) clearance for the COLOR VUE TM- MYCOPLASMA PNEUMONIAE, a Antisera, All Mycoplasma Spp. (Class I — General Controls, product code GSA), submitted by Seradyn, Inc. (Indianapolis, US). The FDA issued a Cleared decision on June 24, 1991, 117 days after receiving the submission on February 27, 1991. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K910833 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1991
Decision Date June 24, 1991
Days to Decision 117 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary —

Device Classification

Product Code GSA — Antisera, All Mycoplasma Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3375

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