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FDA 510(k)

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO

K-Number: K854108 · 1985-11-12

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1985-11-12
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO 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 1985-11-12 under 510(k) number K854108. 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 POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO?

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO is a medical device that received FDA 510(k) clearance on 1985-11-12. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K854108.

When did POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO receive FDA 510(k) clearance?

POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO received FDA 510(k) clearance on 1985-11-12, under 510(k) number K854108.

Who is the listed applicant for POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO?

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 POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO?

The FDA product code for POLYVALENT FLUORESCENT ANTIBODY REAGENTS FOR LEGIO is LHL.

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Other records listing Medical Diagnostic Technologies, Inc. as applicant

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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.K864006LEGIONELLA PNEUMOPHILA SER. 1 ANTIGEN LATEX TESTMedical 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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