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FDA 510(k)

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD

K-Number: K832896 · 1983-10-14

ApplicantBiodan Medical Systems, Ltd.
Decision Date1983-10-14
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD is the device name listed in this FDA 510(k) record. The listed applicant is Biodan Medical Systems, Ltd.. It received FDA 510(k) clearance on 1983-10-14 under 510(k) number K832896. 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 INDIRECT FLUORESCENT ANTIBOD?

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD is a medical device that received FDA 510(k) clearance on 1983-10-14. The listed applicant is Biodan Medical Systems, Ltd.. The 510(k) number is K832896.

When did LEGIONELLA INDIRECT FLUORESCENT ANTIBOD receive FDA 510(k) clearance?

LEGIONELLA INDIRECT FLUORESCENT ANTIBOD received FDA 510(k) clearance on 1983-10-14, under 510(k) number K832896.

Who is the listed applicant for LEGIONELLA INDIRECT FLUORESCENT ANTIBOD?

The FDA 510(k) record lists Biodan Medical Systems, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LEGIONELLA INDIRECT FLUORESCENT ANTIBOD?

The FDA product code for LEGIONELLA INDIRECT FLUORESCENT ANTIBOD is LHL.

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Other records listing Biodan Medical Systems, Ltd. as applicant

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K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMEK930261RTM REHABILITATION TREADMILL, MODEL #945-200K930262TREATMENT TABLE, MODEL #825-100K930259TRACTION TABLE MODEL #825-200K926083NUCLEAR PATIENT SANNING TABLES, VARIOUS TYPESK926082CARDIAC STRESS TABLE, 056-180/UNIV ROLL STRESS ATT

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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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