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)

CHLAMYDIA

K-Number: K843654 · 1985-08-08

ApplicantInstitute Virion , Ltd.
Decision Date1985-08-08
Product CodeGPW
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYDIA is the device name listed in this FDA 510(k) record. The listed applicant is Institute Virion , Ltd.. It received FDA 510(k) clearance on 1985-08-08 under 510(k) number K843654. The device is classified under product code GPW. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHLAMYDIA?

CHLAMYDIA is a medical device that received FDA 510(k) clearance on 1985-08-08. The listed applicant is Institute Virion , Ltd.. The 510(k) number is K843654.

When did CHLAMYDIA receive FDA 510(k) clearance?

CHLAMYDIA received FDA 510(k) clearance on 1985-08-08, under 510(k) number K843654.

Who is the listed applicant for CHLAMYDIA?

The FDA 510(k) record lists Institute Virion , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHLAMYDIA?

The FDA product code for CHLAMYDIA is GPW.

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 Institute Virion , Ltd. 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.

K862814COMPLEMENT-FIXATION TEST FOR CAMPYLOBACTER JEJUNIK843662MEASLES VIRUS RUBEOLAK843660IN FLUENZA B VIRUSK843657CYTOMEGALOVIRUSK843658H. SIMPLEX VIRUSK843673RESPIRATORY SYNCYTIAL VIRUS

View all 16 devices →

Related Devices (Code: GPW)

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.

K872700YHLAMYDIA CF ANTIGEN AND CONTROL ANTIGENSita, Inc.K844868CHLAMYDIA GROUP CF ANTIGENHillcrest BiologicalsK811570ANTIBODY TO CHLAMYDIA TRACHOMATISElectro-Nucleonics 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.

↑