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 ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY

K-Number: K933997 · 1993-11-22

ApplicantAlexon Biomedical, Inc.
Decision Date1993-11-22
Product CodeGMD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PROSPECT ENTAMOEBA HISTOLYTICA 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 1993-11-22 under 510(k) number K933997. The device is classified under product code GMD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY?

PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY is a medical device that received FDA 510(k) clearance on 1993-11-22. The listed applicant is Alexon Biomedical, Inc.. The 510(k) number is K933997.

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

PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY received FDA 510(k) clearance on 1993-11-22, under 510(k) number K933997.

Who is the listed applicant for PROSPECT ENTAMOEBA HISTOLYTICA 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 ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY?

The FDA product code for PROSPECT ENTAMOEBA HISTOLYTICA MICROPLATE ASSAY is GMD.

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 ASSAYK874849PROSPECT/GIARDIA

Related Devices (Code: GMD)

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.

K112422CRAG LATERAL FLOW ASSAY (LFA)Immuno-Mycologics, Inc.K102286CRAG LATERAL FLOW ASSAY (CRAG LFA)Immuno-Mycologics, Inc.K930418CRYPTO-LEX SYSTEMTrinity Laboratories, Inc.K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEMeridian Diagnostics, Inc.K812188CRYPTOCOCCAL ANTIGEN LATEX AGGLUTIAmerican Scientific ProductsK810510YA-CRYPTO ANTIBODY TUBE AGGLUTINATIONImmuno-Mycologics, 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.

↑