Cleared Traditional

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120

K963055 · Genbio · Microbiology
May 1997
Decision
269d
Days
Class 1
Risk

About This 510(k) Submission

K963055 is an FDA 510(k) clearance for the IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120, 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 2, 1997, 269 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 K963055 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1996
Decision Date May 02, 1997
Days to Decision 269 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

Similar Devices — LJZ Enzyme Linked Immunoabsorbent Assay, Mycoplasma Spp.

All 12
THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.
K984153 · Zeus Scientific, Inc. · Jan 1999
MYCOPLASMA IGM ELISA TEST SYSTEM
K971503 · Zeus Scientific, Inc. · Aug 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K971393 · Immunoprobe, Inc. · Jul 1997
MYCOPLASMA IGG ELISA TEST SYSTEM
K970150 · Zeus Scientific, Inc. · Jun 1997
IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)
K963054 · Genbio · May 1997
IMMUNOCARD MYCOPLASMA
K934550 · Meridian Diagnostics, Inc. · Sep 1994