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FDA 510(k)

LUMATAG T4 CHEMILUMINESCENCE ASSAY

K-Number: K911985 · 1991-08-02

ApplicantLondon Diagnostics, Inc.
Decision Date1991-08-02
Product CodeCDX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

LUMATAG T4 CHEMILUMINESCENCE 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 1991-08-02 under 510(k) number K911985. The device is classified under product code CDX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LUMATAG T4 CHEMILUMINESCENCE ASSAY?

LUMATAG T4 CHEMILUMINESCENCE ASSAY is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is London Diagnostics, Inc.. The 510(k) number is K911985.

When did LUMATAG T4 CHEMILUMINESCENCE ASSAY receive FDA 510(k) clearance?

LUMATAG T4 CHEMILUMINESCENCE ASSAY received FDA 510(k) clearance on 1991-08-02, under 510(k) number K911985.

Who is the listed applicant for LUMATAG T4 CHEMILUMINESCENCE 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 LUMATAG T4 CHEMILUMINESCENCE ASSAY?

The FDA product code for LUMATAG T4 CHEMILUMINESCENCE ASSAY is CDX.

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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 ASSAYK912858LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN 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: CDX)

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.

K961490ELECSYS T4 ASSAYBoehringer Mannheim Corp.K954312ACTIVE THYROXINE RIADiagnostic Systems Laboratories, Inc.K943416DELFIA NEONATAL THYROXINE KITWallac OYK934384AXSYM(TM) TOTAL T4Abbott LaboratoriesK932980TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116Sigma Diagnostics, Inc.K933426STRATUS(R) TOTAL THYROXINE(T4) FLUOR ENZYME IMMUNOBaxter Diagnostics, 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.

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