Cleared Traditional

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)

K963054 · Genbio · Microbiology
May 1997
Decision
272d
Days
Class 1
Risk

About This 510(k) Submission

K963054 is an FDA 510(k) clearance for the IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130), a Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp. (Class I — General Controls, product code LJZ), submitted by Genbio (San Diego, US). The FDA issued a Cleared decision on May 5, 1997, 272 days after receiving the submission on August 6, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3375.

Submission Details

510(k) Number K963054 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1996
Decision Date May 05, 1997
Days to Decision 272 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code LJZ — Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3375

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