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FDA 510(k)

LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST

K-Number: K864006 · 1987-04-20

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1987-04-20
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST 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 1987-04-20 under 510(k) number K864006. The device is classified under product code LHL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST?

LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST is a medical device that received FDA 510(k) clearance on 1987-04-20. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K864006.

When did LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST receive FDA 510(k) clearance?

LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST received FDA 510(k) clearance on 1987-04-20, under 510(k) number K864006.

Who is the listed applicant for LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST?

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 LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST?

The FDA product code for LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TEST is LHL.

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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

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Related Devices (Code: LHL)

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.

K984123THE APTUS (AUTOMATED) APPLICATION OF THE LEGIONELLA IGG/A/M (ELISA) TEST SYSTEM. AN ENZYME LINKED IMMUNOSORBENT ASSAY (EZeus Scientific, Inc.K970149LEGIONELLA ELISA TEST SYSTEMZeus Scientific, Inc.K963318LEGIONELLA IGG/IGM ELISA TEST SYSTEMArmkel, LLCK921421LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODYPro-Lab, Inc.K871328DU PONT LEGIONELLA URINARY ANTIGEN - RIA KITE.I. Dupont DE Nemours & Co., Inc.K854108POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIOMedical Diagnostic Technologies, Inc.

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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