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FDA 510(k)

PROSPECT/GIARDIA

K-Number: K874849 · 1988-01-05

ApplicantAlexon Biomedical, Inc.
Decision Date1988-01-05
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT/GIARDIA is the device name listed in this FDA 510(k) record. The listed applicant is Alexon Biomedical, Inc.. It received FDA 510(k) clearance on 1988-01-05 under 510(k) number K874849. The device is classified under product code KHW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT/GIARDIA?

PROSPECT/GIARDIA is a medical device that received FDA 510(k) clearance on 1988-01-05. The listed applicant is Alexon Biomedical, Inc.. The 510(k) number is K874849.

When did PROSPECT/GIARDIA receive FDA 510(k) clearance?

PROSPECT/GIARDIA received FDA 510(k) clearance on 1988-01-05, under 510(k) number K874849.

Who is the listed applicant for PROSPECT/GIARDIA?

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

What is the FDA product code for PROSPECT/GIARDIA?

The FDA product code for PROSPECT/GIARDIA is KHW.

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 Biomedical, 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.

K964864PROSPECT II CLOSTRIDIUM DIFFILLIE TOXIN A MICROPLATE ASSAYK955157PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAYK936191PROSPECT CRYPTOSPORIDIUM RAPID ASSAYK933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY

Related Devices (Code: KHW)

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.

K170728E. HISTOLYTICA QUIK CHEKTechlab, Inc.K994101E. HISTOLYTICA IITechlab, Inc.K955895E. HISTOLYTICA TESTTechlab, Inc.K954996TREND AMEBIASIS (E.HISTOLYTICA) SEROLOGICAL ELISA TEST SYSTEMTrend Scientific, Inc.K944791ENTAMOEBA TESTTechlab, Inc.K900604DIRECT FLUORESCENT ANTIBODY REAGENT FOR GIARDIABiovir Laboratories, 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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