Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM

K-Number: K921556 · 1992-06-29

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1992-06-29
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1992-06-29 under 510(k) number K921556. 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 IGG/IGM ANTIBODY TEST SYSTEM?

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1992-06-29. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K921556.

When did MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM receive FDA 510(k) clearance?

MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM received FDA 510(k) clearance on 1992-06-29, under 510(k) number K921556.

Who is the listed applicant for MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM?

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

What is the FDA product code for MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY TEST SYSTEM?

The FDA product code for MYCOPLASMA PNEUMONIAE IGG/IGM ANTIBODY 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medical Diagnostic Technologies, 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.

K062229CTC WORKSTATION, MODEL 2200K972209SPECTROLYSE HEPARIN (ANTI-IIA)K963106CHROMOLIZE PAI-1 KITK960871SPECTROLYSE ANTITHROMBIN III (ANTI-XA)K962489CHROMOLIZE TPA ASSAY KITK960438TINTELIZE PAI-1 KIT

View all 57 devices →

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.

↑