IMMUNOCARD MYCOPLASMA— 510(k) K934550

Name: FDA 510(k) clearance K934550
Creator: U.S. Food and Drug Administration
Published: 1994-09-20

Substantially Equivalent

Meridian Diagnostics, Inc.

FDA 510(k) clearance K934550 for IMMUNOCARD MYCOPLASMA, Substantially Equivalent on 1994-09-20. Applicant: Meridian Diagnostics, Inc.. Device class: 1.

Clearance details

Applicant: Meridian Diagnostics, Inc.
Product code: Code LJZ
Device class: Class 1
Regulation: 21 CFR 866.3375
Advisory panel: Microbiology
Date received: 1993-09-22
Decision date: 1994-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJZ

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K984153 — THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.1999-01-11
K971503 — MYCOPLASMA IGM ELISA TEST SYSTEM1997-08-20
K971393 — MYCOPLASMA IGG ELISA TEST SYSTEM1997-07-14
K970150 — MYCOPLASMA IGG ELISA TEST SYSTEM1997-06-16
K963054 — IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)1997-05-05

More clearances from Meridian Diagnostics, Inc.

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K993914 — PREMIER TOXINS A&B, MODEL 6160961999-12-10
K990263 — IMMUNOCARD STAT! E. COLI O157:H71999-08-09
K984343 — PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST1999-06-25
K984346 — PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST1999-06-25
K983255 — MODIFICATION TO: PREMIER PLATINUM HPSA1998-12-17

Recalls naming K934550

K-number listed on FDA's recall record

Z-1299-2021 — The ImmunoCard Mycoplasma EIA detects the presence of IgM to M. pneumoniae in serum - Product Usage: intended to aid in the diagnosis of recent Mycoplasma pneumoniae infection.Class II·Terminated·Meridian Bioscience Inc·20210208

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K934550.

Data sourced from openFDA. This site is unofficial and independent of the FDA.