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FDA 510(k)

DIRECT FA CONJUGATE FOR LEGIONELLA SP

K-Number: K813339 · 1981-12-18

ApplicantSpringwood Microbiologicals
Decision Date1981-12-18
Product CodeLHL
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIRECT FA CONJUGATE FOR LEGIONELLA SP is the device name listed in this FDA 510(k) record. The listed applicant is Springwood Microbiologicals. It received FDA 510(k) clearance on 1981-12-18 under 510(k) number K813339. 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 DIRECT FA CONJUGATE FOR LEGIONELLA SP?

DIRECT FA CONJUGATE FOR LEGIONELLA SP is a medical device that received FDA 510(k) clearance on 1981-12-18. The listed applicant is Springwood Microbiologicals. The 510(k) number is K813339.

When did DIRECT FA CONJUGATE FOR LEGIONELLA SP receive FDA 510(k) clearance?

DIRECT FA CONJUGATE FOR LEGIONELLA SP received FDA 510(k) clearance on 1981-12-18, under 510(k) number K813339.

Who is the listed applicant for DIRECT FA CONJUGATE FOR LEGIONELLA SP?

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

What is the FDA product code for DIRECT FA CONJUGATE FOR LEGIONELLA SP?

The FDA product code for DIRECT FA CONJUGATE FOR LEGIONELLA SP is LHL.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Springwood Microbiologicals 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.

K812013FLUORESCENT ANTIBODY CONJUGATE FOR GP.A

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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