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FDA 510(k)

LEGIONELLA ELISA TEST SYSTEM

K-Number: K970149 · 1997-06-18

ApplicantZeus Scientific, Inc.
Decision Date1997-06-18
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA ELISA TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Zeus Scientific, Inc.. It received FDA 510(k) clearance on 1997-06-18 under 510(k) number K970149. 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 ELISA TEST SYSTEM?

LEGIONELLA ELISA TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1997-06-18. The listed applicant is Zeus Scientific, Inc.. The 510(k) number is K970149.

When did LEGIONELLA ELISA TEST SYSTEM receive FDA 510(k) clearance?

LEGIONELLA ELISA TEST SYSTEM received FDA 510(k) clearance on 1997-06-18, under 510(k) number K970149.

Who is the listed applicant for LEGIONELLA ELISA TEST SYSTEM?

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

What is the FDA product code for LEGIONELLA ELISA TEST SYSTEM?

The FDA product code for LEGIONELLA ELISA TEST SYSTEM is LHL.

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Other records listing Zeus Scientific, 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.

K201956Zeus IFA ANA HEp-2 Test System, Zeus dIFineK191240ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgM Test SystemK190907ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG/IgM Test SystemK191398ZEUS ELISA Borrelia VlsE1/pepC10 IgG/IgM Test System; ZEUS ELISA Borrelia burgdorferi IgG Test SystemK113397ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEMK102425ZEUS ELISA CARDIOLIPIN IGG/IGM/IGA TEST SYSTEM

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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.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.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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