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FDA 510(k)

IMMUNOCARD MYCOPLASMA

K-Number: K934550 · 1994-09-20

ApplicantMeridian Diagnostics, Inc.
Decision Date1994-09-20
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

IMMUNOCARD MYCOPLASMA is the device name listed in this FDA 510(k) record. The listed applicant is Meridian Diagnostics, Inc.. It received FDA 510(k) clearance on 1994-09-20 under 510(k) number K934550. The device is classified under product code LJZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMUNOCARD MYCOPLASMA?

IMMUNOCARD MYCOPLASMA is a medical device that received FDA 510(k) clearance on 1994-09-20. The listed applicant is Meridian Diagnostics, Inc.. The 510(k) number is K934550.

When did IMMUNOCARD MYCOPLASMA receive FDA 510(k) clearance?

IMMUNOCARD MYCOPLASMA received FDA 510(k) clearance on 1994-09-20, under 510(k) number K934550.

Who is the listed applicant for IMMUNOCARD MYCOPLASMA?

The FDA 510(k) record lists Meridian Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IMMUNOCARD MYCOPLASMA?

The FDA product code for IMMUNOCARD MYCOPLASMA is LJZ.

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Other records listing Meridian Diagnostics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K993914PREMIER TOXINS A&B, MODEL 616096K990263IMMUNOCARD STAT! E. COLI O157:H7K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTK984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTK983255MODIFICATION TO: PREMIER PLATINUM HPSAK982764PREMIER CRYPTOSPORIDIUM

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Related Devices (Code: LJZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K984153THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.Zeus Scientific, Inc.K971503MYCOPLASMA IGM ELISA TEST SYSTEMZeus Scientific, Inc.K971393MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.K970150MYCOPLASMA IGG ELISA TEST SYSTEMZeus Scientific, Inc.K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)GenbioK963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120Genbio

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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