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)

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)

K-Number: K854017 · 1985-10-22

ApplicantLmd Laboratories
Decision Date1985-10-22
Product CodeKHW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) is the device name listed in this FDA 510(k) record. The listed applicant is Lmd Laboratories. It received FDA 510(k) clearance on 1985-10-22 under 510(k) number K854017. 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 ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)?

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) is a medical device that received FDA 510(k) clearance on 1985-10-22. The listed applicant is Lmd Laboratories. The 510(k) number is K854017.

When did ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) receive FDA 510(k) clearance?

ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) received FDA 510(k) clearance on 1985-10-22, under 510(k) number K854017.

Who is the listed applicant for ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)?

The FDA 510(k) record lists Lmd Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT)?

The FDA product code for ENTAMOEBA HISTOLYTICA-POSITIVE CONTROL(RABBIT) 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 Lmd Laboratories 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.

K955345LMD CRYPTOSPORIDIUM ANTIGEN DETECTIONK942705E. COLI 0157 ELISA STOOL ASSAYK944871LMD GIARDIA ANTIGEN DETECTION ASSAYK905598CRYPTOSPORIDIUM ANTIGEN DETECTIONK904613TRICHINELLA SEROLOGY MICROTITER ELISAK900780CYSTICERCOSIS SEROLOGICAL REAGENTS

View all 12 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑