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FDA 510(k)

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY

K-Number: K982315 · 1998-11-18

ApplicantAlexon - Trend, Inc.
Decision Date1998-11-18
Product CodeLQP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Alexon - Trend, Inc.. It received FDA 510(k) clearance on 1998-11-18 under 510(k) number K982315. The device is classified under product code LQP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT CAMPYLOBACTER MICROPLATE ASSAY?

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 1998-11-18. The listed applicant is Alexon - Trend, Inc.. The 510(k) number is K982315.

When did PROSPECT CAMPYLOBACTER MICROPLATE ASSAY receive FDA 510(k) clearance?

PROSPECT CAMPYLOBACTER MICROPLATE ASSAY received FDA 510(k) clearance on 1998-11-18, under 510(k) number K982315.

Who is the listed applicant for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY?

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

What is the FDA product code for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY?

The FDA product code for PROSPECT CAMPYLOBACTER MICROPLATE ASSAY is LQP.

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 Alexon - Trend, 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.

K982709MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER ASSAYK980507PROSPECT SHIGA TOXIN MICROPLATE ASSAY

Related Devices (Code: LQP)

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.

K210976Curian CampyMeridian Bioscience, Inc.K211342Sofia 2 Campylobacter FIAQuidel CorporationK191456Campylobacter Quik ChekTechlab, Inc.K191442Campylobacter ChekTechlab, Inc.K173217CAMPYLOBACTER QUIK CHEKTechlab, Inc.K173219CAMPYLOBACTER CHEKTechlab, 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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