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)

BINAX IRMA TOTAL BETA-HCG TEST KIT

K-Number: K872728 · 1987-08-05

ApplicantBinax, Inc.
Decision Date1987-08-05
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BINAX IRMA TOTAL BETA-HCG TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Binax, Inc.. It received FDA 510(k) clearance on 1987-08-05 under 510(k) number K872728. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BINAX IRMA TOTAL BETA-HCG TEST KIT?

BINAX IRMA TOTAL BETA-HCG TEST KIT is a medical device that received FDA 510(k) clearance on 1987-08-05. The listed applicant is Binax, Inc.. The 510(k) number is K872728.

When did BINAX IRMA TOTAL BETA-HCG TEST KIT receive FDA 510(k) clearance?

BINAX IRMA TOTAL BETA-HCG TEST KIT received FDA 510(k) clearance on 1987-08-05, under 510(k) number K872728.

Who is the listed applicant for BINAX IRMA TOTAL BETA-HCG TEST KIT?

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

What is the FDA product code for BINAX IRMA TOTAL BETA-HCG TEST KIT?

The FDA product code for BINAX IRMA TOTAL BETA-HCG TEST KIT is JHI.

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 Binax, 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.

K090301BINAXNOW PBP2A TEST, MODEL 890-000K091766CLEARVIEW EXACT PBP2A TEST, MODEL 891-000K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTK091489CLEARVIEW ADVANCED STREP A , MODEL 737-430K083744BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010K092223MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST

View all 30 devices →

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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.

↑