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FDA 510(k)

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT

K-Number: K871328 · 1987-09-02

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1987-09-02
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1987-09-02 under 510(k) number K871328. 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 DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT?

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT is a medical device that received FDA 510(k) clearance on 1987-09-02. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K871328.

When did DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT receive FDA 510(k) clearance?

DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT received FDA 510(k) clearance on 1987-09-02, under 510(k) number K871328.

Who is the listed applicant for DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT?

The FDA product code for DU PONT LEGIONELLA URINARY ANTIGEN - RIA KIT is LHL.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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.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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