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FDA 510(k)

LEGIONELLA DFA KIT I

K-Number: K830820 · 1983-06-08

ApplicantBionetic Laboratory Products
Decision Date1983-06-08
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA DFA KIT I is the device name listed in this FDA 510(k) record. The listed applicant is Bionetic Laboratory Products. It received FDA 510(k) clearance on 1983-06-08 under 510(k) number K830820. 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 DFA KIT I?

LEGIONELLA DFA KIT I is a medical device that received FDA 510(k) clearance on 1983-06-08. The listed applicant is Bionetic Laboratory Products. The 510(k) number is K830820.

When did LEGIONELLA DFA KIT I receive FDA 510(k) clearance?

LEGIONELLA DFA KIT I received FDA 510(k) clearance on 1983-06-08, under 510(k) number K830820.

Who is the listed applicant for LEGIONELLA DFA KIT I?

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

What is the FDA product code for LEGIONELLA DFA KIT I?

The FDA product code for LEGIONELLA DFA KIT I is LHL.

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Other records listing Bionetic Laboratory Products 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.

K833637VZV BIO-ENZABEAD SCREEN KITK832900IMMUNOENZYME TEST SYS-DETECT-IGM ANTIK832069TOXO IPA KIT IAN INDIRECT FLUORESCENTK831760LEGIONELLA IFA KIT IK831133AMEBIASIS BIO-ENZABEAD SCREEN KITK830227AUTOMATED ELISA READER LBI 300

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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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