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)

BETA-HCG HEMAGGLUTINATION TEST

K-Number: K842181 · 1984-08-22

ApplicantSero-Immuno Diagnostics, Inc.
Decision Date1984-08-22
Product CodeJHJ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BETA-HCG HEMAGGLUTINATION TEST is the device name listed in this FDA 510(k) record. The listed applicant is Sero-Immuno Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-08-22 under 510(k) number K842181. 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 BETA-HCG HEMAGGLUTINATION TEST?

BETA-HCG HEMAGGLUTINATION TEST is a medical device that received FDA 510(k) clearance on 1984-08-22. The listed applicant is Sero-Immuno Diagnostics, Inc.. The 510(k) number is K842181.

When did BETA-HCG HEMAGGLUTINATION TEST receive FDA 510(k) clearance?

BETA-HCG HEMAGGLUTINATION TEST received FDA 510(k) clearance on 1984-08-22, under 510(k) number K842181.

Who is the listed applicant for BETA-HCG HEMAGGLUTINATION TEST?

The FDA 510(k) record lists Sero-Immuno Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BETA-HCG HEMAGGLUTINATION TEST?

The FDA product code for BETA-HCG HEMAGGLUTINATION TEST 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 Sero-Immuno Diagnostics, 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.

K852286DIRRECT AGGLUTINATION(DAG) PREGNANCY TESTK834328DAT TEST FOR CHAGAS' DISEASE

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.

↑