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)

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY

K-Number: K912858 · 1991-07-30

ApplicantLondon Diagnostics, Inc.
Decision Date1991-07-30
Product CodeCFL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is London Diagnostics, Inc.. It received FDA 510(k) clearance on 1991-07-30 under 510(k) number K912858. The device is classified under product code CFL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY?

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY is a medical device that received FDA 510(k) clearance on 1991-07-30. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K912858.

When did LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY receive FDA 510(k) clearance?

LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY received FDA 510(k) clearance on 1991-07-30, under 510(k) number K912858.

Who is the listed applicant for LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY?

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

What is the FDA product code for LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY?

The FDA product code for LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY is CFL.

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 London 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.

K914835LUMATAG FREE T4 CHEMILUMINESCENCE ASSAYK911985LUMATAG T4 CHEMILUMINESCENCE ASSAYK905814LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAYK904458LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATIONK903130LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAYK903195LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY

View all 12 devices →

Related Devices (Code: CFL)

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.

K972761SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAYSealite Sciences, Inc.K971353DSL ACTIVE NON-EXTRACTION IGF-I ELISADiagnostic Systems Laboratories, Inc.K970701DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900)Diagnostic Systems Laboratories, Inc.K962758DSL 9100 IGF-II IRMADiagnostic Systems Laboratories, Inc.K961678HUMAN GROWTH HORMONE IMMUNOASSAY KITNichols Institute DiagnosticsK961172DSL ACTIVE NON-EXTRACTION IGF-I IRMADiagnostic Systems 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.

↑