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FDA 510(k)

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM

K-Number: K920212 · 1992-08-20

ApplicantShared Systems, Inc.
Decision Date1992-08-20
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Shared Systems, Inc.. It received FDA 510(k) clearance on 1992-08-20 under 510(k) number K920212. 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 MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM?

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-08-20. The listed applicant is Shared Systems, Inc.. The 510(k) number is K920212.

When did MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM receive FDA 510(k) clearance?

MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM received FDA 510(k) clearance on 1992-08-20, under 510(k) number K920212.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM?

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

What is the FDA product code for MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM?

The FDA product code for MYCOPLASMA PNEUMONIAE ANTIBODY EIA TEST SYSTEM is LJZ.

Related Clinical Trials

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.

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Other records listing Shared Systems, 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.

K973457CHROMALEX E. COLI 0157 LATEX TEST SYSTEM, PROD. NO. 800K955042CHROMALEX C-REACTIVE PROTEIN LATEX TEST SYSTEMK950073MYCOPLASMA PNEUMONIAE ANTIBODY LATEX AGGLUTINATION TEST SYSTEMK953261CHROMALEX RHEUMATOID FACTOR LATEX TEST SYSTEM

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

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

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