FDA 510(k)

LEGIONELLA DIRECT FLUORESCENT ANTIBODY

K-Number: K812006 · 1981-09-08

ApplicantCenters for Disease Control and Prevention

Decision Date1981-09-08

Product CodeLHL

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

LEGIONELLA DIRECT FLUORESCENT ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Centers for Disease Control and Prevention. It received FDA 510(k) clearance on 1981-09-08 under 510(k) number K812006. 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 DIRECT FLUORESCENT ANTIBODY?

LEGIONELLA DIRECT FLUORESCENT ANTIBODY is a medical device that received FDA 510(k) clearance on 1981-09-08. The listed applicant is Centers for Disease Control and Prevention. The 510(k) number is K812006.

When did LEGIONELLA DIRECT FLUORESCENT ANTIBODY receive FDA 510(k) clearance?

LEGIONELLA DIRECT FLUORESCENT ANTIBODY received FDA 510(k) clearance on 1981-09-08, under 510(k) number K812006.

Who is the listed applicant for LEGIONELLA DIRECT FLUORESCENT ANTIBODY?

The FDA 510(k) record lists Centers for Disease Control and Prevention as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGIONELLA DIRECT FLUORESCENT ANTIBODY?

The FDA product code for LEGIONELLA DIRECT FLUORESCENT ANTIBODY is LHL.

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Related Devices (Code: LHL)

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, LLC K921421LEGIONELLA 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

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