Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST

K-Number: K061496 · 2007-06-28

ApplicantSa Scientific , Ltd.
Decision Date2007-06-28
Product CodeMJH
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific , Ltd.. It received FDA 510(k) clearance on 2007-06-28 under 510(k) number K061496. The device is classified under product code MJH. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST?

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST is a medical device that received FDA 510(k) clearance on 2007-06-28. The listed applicant is Sa Scientific , Ltd.. The 510(k) number is K061496.

When did SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST receive FDA 510(k) clearance?

SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST received FDA 510(k) clearance on 2007-06-28, under 510(k) number K061496.

Who is the listed applicant for SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST?

The FDA 510(k) record lists Sa Scientific , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST?

The FDA product code for SAS LEGIONELLA TEST, SAS LEGIONELLA DIPSTICK TEST is MJH.

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 Sa Scientific , Ltd. 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.

K132352SAS FLUALERT A & B, SAS INFLUENZA A TEST

Related Devices (Code: MJH)

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.

K191184ImmuView S pneumoniae and L pneumophila Urinary Antigen TestSsi Diagnostica A/SK163273TRU LegionellaMeridian Bioscience, Inc.K113190TRU LEGIONELLAMeridian Bioscience, Inc.K070522MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012Inverness Medical Professional DiagnosticsK033051LEGIONELLA PNEUMOPHILA IGG/IGMTrinity Biotech USAK991074BARTELS LEGIONELLA URINARY ANTIGEN ELISA TESTIntracel Corp.

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.

↑