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)

PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY

K-Number: K955157 · 1996-02-09

ApplicantAlexon Biomedical, Inc.
Decision Date1996-02-09
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY 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 1996-02-09 under 510(k) number K955157. The device is classified under product code MHI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY?

PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 1996-02-09. The listed applicant is Alexon Biomedical, Inc.. The 510(k) number is K955157.

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

PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY received FDA 510(k) clearance on 1996-02-09, under 510(k) number K955157.

Who is the listed applicant for PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY?

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/CRYPTOSPORIDIUM MICROPLATE ASSAY?

The FDA product code for PROSPECT GIARDIA/CRYPTOSPORIDIUM MICROPLATE ASSAY is MHI.

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 ASSAYK936191PROSPECT CRYPTOSPORIDIUM RAPID ASSAYK933997PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAYK874849PROSPECT/GIARDIA

Related Devices (Code: MHI)

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.

K120001UNIGOLD GIARDIATrinity BiotechK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research CenterK081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFIvd Research, Inc.K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, 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.

↑