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)

LEECO E2 QUANT DIAG. TEST KIT

K-Number: K834586 · 1984-03-09

ApplicantLeeco Diagnostics, Inc.
Decision Date1984-03-09
Product CodeCHP
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LEECO E2 QUANT DIAG. TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Leeco Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-03-09 under 510(k) number K834586. The device is classified under product code CHP. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LEECO E2 QUANT DIAG. TEST KIT?

LEECO E2 QUANT DIAG. TEST KIT is a medical device that received FDA 510(k) clearance on 1984-03-09. The listed applicant is Leeco Diagnostics, Inc.. The 510(k) number is K834586.

When did LEECO E2 QUANT DIAG. TEST KIT receive FDA 510(k) clearance?

LEECO E2 QUANT DIAG. TEST KIT received FDA 510(k) clearance on 1984-03-09, under 510(k) number K834586.

Who is the listed applicant for LEECO E2 QUANT DIAG. TEST KIT?

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

What is the FDA product code for LEECO E2 QUANT DIAG. TEST KIT?

The FDA product code for LEECO E2 QUANT DIAG. TEST KIT is CHP.

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 Leeco 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.

K895765LEECO PREVIEW(R) EBV (EIA)K894122LEECO VIS-DISK STREP-A (EIA)K891095VIS-DISK HCG (EIA) LYOPHILIZED JPL-044MK891096VIS-DISK HCG (EIA) JPL-041MK883269PRL-QUANTK880577CONCEP-7-BHCG

View all 49 devices →

Related Devices (Code: CHP)

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.

K041349LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL IN SALIVA AND SERUMIbl GmbHK97390117 B-ESTRADIOL (ELISA)Kmi Diagnostics, Inc.K973743ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZERBeckman Instruments, Inc.K970386ACS ESTADIOL-6 IIChiron Diagnostics Corp.K970643VITROS IMMUNODIAGNOSTICS PRODUCTS ESTRADIOL REAGENT PACK(GEM. 1050)/ESTRADIOL CALIBRATORS (GEM.C050)Johnson & Johnson Clinical Diagnostics, Inc.K970126ACCESS ESTRADIOL REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER (33550,33540,33545)Bio-Rad 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.

↑