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FDA 510(k)

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY

K-Number: K921421 · 1992-07-28

ApplicantPro-Lab, Inc.
Decision Date1992-07-28
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Pro-Lab, Inc.. It received FDA 510(k) clearance on 1992-07-28 under 510(k) number K921421. 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 REAGENS FOR DIRECT FLUORESCENT ANTIBODY?

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Pro-Lab, Inc.. The 510(k) number is K921421.

When did LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY receive FDA 510(k) clearance?

LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY received FDA 510(k) clearance on 1992-07-28, under 510(k) number K921421.

Who is the listed applicant for LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY?

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

What is the FDA product code for LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY?

The FDA product code for LEGIONELLA REAGENS FOR DIRECT FLUORESCENT ANTIBODY is LHL.

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Other records listing Pro-Lab, Inc. as applicant

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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, LLCK871328DU 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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