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FDA 510(k)

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT

K-Number: K852237 · 1985-08-22

ApplicantGenetic Systems Corp.
Decision Date1985-08-22
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Genetic Systems Corp.. It received FDA 510(k) clearance on 1985-08-22 under 510(k) number K852237. 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 IMMUNOFLUORESCENT ANTIBODY TEST KIT?

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT is a medical device that received FDA 510(k) clearance on 1985-08-22. The listed applicant is Genetic Systems Corp.. The 510(k) number is K852237.

When did LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT receive FDA 510(k) clearance?

LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT received FDA 510(k) clearance on 1985-08-22, under 510(k) number K852237.

Who is the listed applicant for LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT?

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

What is the FDA product code for LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT?

The FDA product code for LEGIONELLA IMMUNOFLUORESCENT ANTIBODY TEST KIT is LHL.

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Other records listing Genetic Systems Corp. 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.

K891767GENETIC SYSTEMS MICROPLATE READERK891765GENETIC SYSTEMS PIPETTOR/DILUTORK891768GENETIC SYSTEMS MICROPLATE WASHERK891766GENETIC SYSTEMS MICROPLATE STRIP WASHERK890768PNEUMOCYSTIS CARINII IMMUNOFLUORESCENCE TEST KITK873564GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES

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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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