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)

TERUMO SENSIBEAD EIG HCG KIT

K-Number: K854670 · 1986-02-13

ApplicantTerumo Medical Corp.
Decision Date1986-02-13
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TERUMO SENSIBEAD EIG HCG KIT is the device name listed in this FDA 510(k) record. The listed applicant is Terumo Medical Corp.. It received FDA 510(k) clearance on 1986-02-13 under 510(k) number K854670. The device is classified under product code JHJ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TERUMO SENSIBEAD EIG HCG KIT?

TERUMO SENSIBEAD EIG HCG KIT is a medical device that received FDA 510(k) clearance on 1986-02-13. The listed applicant is Terumo Medical Corp.. The 510(k) number is K854670.

When did TERUMO SENSIBEAD EIG HCG KIT receive FDA 510(k) clearance?

TERUMO SENSIBEAD EIG HCG KIT received FDA 510(k) clearance on 1986-02-13, under 510(k) number K854670.

Who is the listed applicant for TERUMO SENSIBEAD EIG HCG KIT?

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

What is the FDA product code for TERUMO SENSIBEAD EIG HCG KIT?

The FDA product code for TERUMO SENSIBEAD EIG HCG KIT is JHJ.

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 Terumo Medical Corp. 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.

K111606PINNACLE PRECISION ACCESS SYSTEMK111556GLIDECROSS SUPPORT CATHETERK110540TERUMO SUPPORT CATHETERK102008GLIDESHEATHK091329PINNACLE DESTINATION PERIPHERAL GUIDING SHEATHK082997TERUMO HYBRIA CLOSED SYSTEM SAFETY I.V. CATHETER

View all 143 devices →

Related Devices (Code: JHJ)

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.

K972606PREGNACOL PREGNANCY TESTImmunostics Inc.,K921968IN VITRO DIAGNOSTIC REAGENT SET, INDIR. PREG. TESTTech-Co, Inc.K935863SAS(TM) DIRECT MONOCLONAL HCGSa Scientific, Inc.K926112ACCUTEX BETA-HCG TESTJ.S. Medical Assoc.K930609SAS(TM) MONOCLONAL HCG-SLIDESa Scientific, Inc.K920716DIRECT PREGNANCY TESTTech-Co, 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.

↑