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FDA 510(k)

INDIRECT FLUORESCENT ANTIBODY REAGENTS

K-Number: K831026 · 1983-06-22

ApplicantZeus Technologies
Decision Date1983-06-22
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

INDIRECT FLUORESCENT ANTIBODY REAGENTS is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Technologies. It received FDA 510(k) clearance on 1983-06-22 under 510(k) number K831026. 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 INDIRECT FLUORESCENT ANTIBODY REAGENTS?

INDIRECT FLUORESCENT ANTIBODY REAGENTS is a medical device that received FDA 510(k) clearance on 1983-06-22. The listed applicant is Zeus Technologies. The 510(k) number is K831026.

When did INDIRECT FLUORESCENT ANTIBODY REAGENTS receive FDA 510(k) clearance?

INDIRECT FLUORESCENT ANTIBODY REAGENTS received FDA 510(k) clearance on 1983-06-22, under 510(k) number K831026.

Who is the listed applicant for INDIRECT FLUORESCENT ANTIBODY REAGENTS?

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

What is the FDA product code for INDIRECT FLUORESCENT ANTIBODY REAGENTS?

The FDA product code for INDIRECT FLUORESCENT ANTIBODY REAGENTS is LHL.

Related Clinical Trials

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Other records listing Zeus Technologies 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.

K840012INDIRECT FLUORESCENT ANTIBODY MYCOK830783VERI-STAPHK822859DIRECT FA CONJUGATE FOR LEGIONELLA SPP

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

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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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